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Irritable Bowel Syndrome (IBS)

Tundra lists 44 Irritable Bowel Syndrome (IBS) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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ENROLLING BY INVITATION

NCT07768267

Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome

The goal of this clinical trial is to learn if an herbal supplement called Biocidin REMOVE can clear small intestinal bacterial overgrowth (SIBO) in adults with irritable bowel syndrome (IBS). SIBO means there are too many bacteria in the small intestine. It can make IBS symptoms worse. This is a small first study, called a pilot study. Its results will help researchers plan larger studies. The main questions it aims to answer are: Does Biocidin REMOVE clear SIBO? Does it lower IBS symptoms and improve quality of life? Does it change the mix of bacteria in the gut? Researchers will compare Biocidin REMOVE to a placebo. A placebo is a look-alike capsule that contains no active ingredients. Neither the participants nor the research team will know who gets which one. About 40 adults age 18 and older will take part. Participants will: Take capsules by mouth twice a day for about 5 weeks. Participants will start with a low dose and build up to 2 capsules twice a day. Take a breath test at the start and at the end of treatment. This test checks for SIBO. Collect a stool sample at home at the start and at the end of treatment. Answer questions about symptoms and quality of life. Report what was eaten during the study. Come back for one check-in about 4 weeks after treatment ends.

Gender: All

Ages: 18 Years - Any

Updated: 2026-11-03

1 state

Irritable Bowel Syndrome (IBS)
Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
RECRUITING

NCT07914478

Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome

This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits. It was hypothesized that vitamin D supplementation would reduce symptom severity and increase blood vitamin D levels compared with placebo. The study was a randomized, placebo-controlled trial at the Department of Pediatrics, Aziz Bhatti Shaheed Teaching Hospital, Gujrat, Pakistan. It included 60 children aged 6-14 years who met established diagnostic criteria for irritable bowel syndrome and had low blood vitamin D levels of 10-29 ng/mL. Children were randomly assigned to two groups of 30 participants each. One group received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks. The other group received matching placebo drops without vitamin D for the same period. Both groups received routine supportive care, including advice on hydration, regular meals, diet, and symptom management. Follow-up visits were scheduled at 4, 8, and 12 weeks to assess symptoms, treatment adherence, and possible side effects. The main outcome was the change in symptom severity from the start of treatment to 12 weeks, measured using a standardized symptom score. The secondary outcome was the change in blood vitamin D levels over the same period. Changes in both outcomes were compared between the two groups.

Gender: All

Ages: 6 Years - 14 Years

Updated: 2026-11-03

1 state

Irritable Bowel Syndrome (IBS)
Vitamin D Deficiency
COMPLETED

NCT07902882

A Clinical Trial to Examine the Effects of Gut Health Supplements to Improve Gut and Digestive Health and Function

This is a double-blind, randomized, placebo-controlled trial evaluating the efficacy of JSHealth's Debloat \& Detox supplement, used alone or in combination with their Probiotics supplement, on gut and digestive health and function in 60 female participants aged 18-45 with self-reported bloating and digestive discomfort. Participants will be randomly assigned to either the intervention or placebo group for eight weeks. During the first four weeks, intervention participants will take the Debloat \& Detox supplement and placebo participants will take a corresponding placebo. During weeks five through eight, intervention participants will add the Probiotic supplement and placebo participants will add a probiotic placebo. Outcomes will be assessed via study-specific questionnaires and abdominal circumference measurements at Baseline, Day 1 (after first use), and at the end of Weeks 2, 4, 6, and 8.

Gender: FEMALE

Ages: 18 Years - 45 Years

Updated: 2026-10-29

1 state

Bloating
Digestive Discomfort
Irritable Bowel Syndrome (IBS)
+3
NOT YET RECRUITING

NCT07890948

NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY

Randomized, single-blind, sham-controlled crossover study evaluating the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in adult patients with IBS. Two intervention groups will receive the investigational NurosymTM device and be randomized (1:1) to either the ACTIVE or SHAM crossover taVNS group. After randomization, participants will receive 8 weeks of active stimulation (ACTIVE) or 4 weeks of sham followed by 4 weeks of active stimulation (SHAM crossover).

Gender: All

Ages: 18 Years - 60 Years

Updated: 2026-10-23

Irritable Bowel Syndrome (IBS)
NOT YET RECRUITING

NCT07882953

SIMBA in Irritable Bowel Syndrome (IBS)

This study is intended to characterize longitudinal changes in the small intestinal microbiome following rifaximin treatment in participants with Irritable Bowel Syndrome (IBS) over a 12 week period.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-10-20

1 state

Irritable Bowel Syndrome (IBS)
Microbiome
ENROLLING BY INVITATION

NCT07872514

Personalized Probiotic Treatments for Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is characterized by stomach pain and altered bowel habits. It affects about 5 million people in Canada. Doctors don't fully understand what causes IBS, so treatments often don't work well. Many patients say certain foods make their symptoms worse. This may be due to how gut bacteria break down food. Some bacteria produce harmful chemicals like histamine and lysophosphatidylcholine (LPC)/lysophosphatidic acid (LPA), which can cause pain and gut problems. These chemicals may affect about 35% of IBS patients. The goal is to find out which patients have these bacteria. Then, doctors can give them treatments that match their gut bacteria. This could help reduce symptoms and improve their lives. If the study is successful, it could change how we understand, diagnose, and treat IBS, leading to new treatments that focus on personalized microbiota-directed treatments targeting specific causative mechanisms.

Gender: All

Ages: 18 Years - 70 Years

Updated: 2026-10-13

1 state

Irritable Bowel Syndrome (IBS)
RECRUITING

NCT07125625

Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome

What is this study about? This clinical study aims to investigate whether a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two). These symptoms can seriously affect a child's daily life and wellbeing. The study is coordinated by the University of Bari, in collaboration with the University of Udine, and led by Prof. Ruggiero Francavilla. Why is this study being done? Although probiotics are increasingly used in IBS, solid scientific evidence in children is still limited. This study will assess whether the chosen probiotic mix improves symptoms, bowel habits, and quality of life in young people with IBS. It will also investigate how the probiotics affect gut bacteria (microbiota) and the chemicals produced by the body (metabolomics), to better understand how these changes might help relieve symptoms. Who can take part? Children and adolescents aged 4 to 18 years with a diagnosis of IBS (based on international Rome IV criteria) who experience abdominal pain on a daily basis. Children with other significant medical conditions, recent surgery, or ongoing infections, as well as those taking antibiotics or other probiotics shortly before the study, cannot participate. How does the study work? The study is a randomised, double-blind, placebo-controlled trial, meaning that some children will receive the probiotic drops, and others will receive placebo drops (which do not contain probiotics), and neither the participants nor the doctors will know who is receiving which treatment. This is the best way to test whether the probiotics really work. Each participant will be involved in the study for about 14 weeks, divided into: A 2-week "run-in" period to confirm eligibility. An 8-week treatment period (probiotic or placebo). A 4-week follow-up. The probiotics/placebo are taken as 20 drops once daily for 8 weeks. Throughout the study, children and parents will be asked to keep a daily diary of abdominal pain and bowel habits, and to complete validated questionnaires on symptom severity and quality of life. Stool and urine samples will also be collected at different time points to analyse changes in gut bacteria and body metabolism. What are the aims of the study? Primary aim: To see whether the probiotics reduce abdominal pain by at least 30% compared to the start of the study. Secondary aims: To check if bowel habits improve (stool consistency and frequency). To assess improvements in quality of life. To analyse whether the probiotics cause positive changes in gut bacteria and metabolic profiles. To ensure that the treatment is safe and well-tolerated. What are the possible risks and benefits? The probiotic mixture used in this study has been studied in children before and is generally considered safe. The study includes careful monitoring for any side effects. Participants may or may not experience an improvement in symptoms. However, the information gained from the study will help doctors better understand how probiotics work in IBS and may benefit future patients. What are participants' rights? Participation is voluntary, and families may withdraw their child from the study at any time, without affecting the child's medical care. The study has been approved by an independent ethics committee and complies with all European and Italian regulations regarding research in children. All personal data and medical information will be treated confidentially and securely, in accordance with privacy laws. Where is the study taking place? The study is being conducted at the Paediatric Gastroenterology Unit of the University of Bari Aldo Moro and the Paediatric Unit of the University of Udine. These centres are national referral centres for children with gastrointestinal problems. Who is funding and organising the study? The study is sponsored and conducted by the University of Bari. The probiotic and placebo products are provided by Dicofarm S.p.A., who also ensures that the placebo and probiotic products look and taste the same to maintain the study's blinding.

Gender: All

Ages: 4 Years - 18 Years

Updated: 2026-10-08

3 states

Irritable Bowel Syndrome (IBS)
NOT YET RECRUITING

NCT07852819

Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms

The goal of this observational case-control study is to learn how stressful experiences, dietary habits, and blood nutrient levels are associated with gastrointestinal symptoms and symptoms of depression and anxiety in adults aged 18 to 65 years. The study will also examine whether positive psychological resources, such as hope, optimism, resilience, and self-confidence, are related to these associations. The main questions this study aims to answer are: * Are stressful experiences in childhood and recent stressful life events associated with gastrointestinal symptoms and symptoms of depression and anxiety? * Are dietary habits and blood levels of selected nutrients associated with gastrointestinal and psychological symptoms? * Do psychological resources, such as hope, optimism, resilience, and self-confidence, influence the relationships among stress, nutrition, gastrointestinal symptoms, and psychological well-being? Researchers will compare 100 participants with gastrointestinal disorders and psychological symptoms or a history of stress with 100 control participants who do not have chronic gastrointestinal symptoms and have low levels of depression and anxiety symptoms. Participants will: * Complete questionnaires about stressful experiences, dietary habits, gastrointestinal symptoms, depression and anxiety symptoms, psychological resources, and quality of life. * Have gastrointestinal sounds recorded. * Allow blood remaining from routine clinical testing performed before endoscopy to be used to measure cholesterol, vitamin B6, and vitamin C levels. No additional blood draw will be required for this study. All study assessments will be completed once at enrollment. There will be no follow-up visits, and participants will not receive or be assigned to any treatment as part of this study.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-10-01

Irritable Bowel Syndrome (IBS)
Functional Dyspepsia
Inflammatory Bowel Disease (IBD)
+3
RECRUITING

NCT07000227

Mechanism of FODMAP Restriction on FGID Patients

Brief Summary : The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is : How does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients. Participants will : Be given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks. Be required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention

Gender: All

Ages: 18 Years - Any

Updated: 2026-09-25

1 state

Functional Gastrointestinal Disorders (FGIDs)
Irritable Bowel Syndrome (IBS)
Functional Dyspepsia
SUSPENDED

NCT04031469

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Gender: All

Ages: 12 Years - Any

Updated: 2026-09-21

1 state

Gut Microbiome
Gastrointestinal Microbiome
Autism
+77
RECRUITING

NCT07222943

Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet. Participants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application. This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.

Gender: All

Ages: 7 Years - 12 Years

Updated: 2026-09-17

1 state

Functional Abdominal Pain Disorders
Irritable Bowel Syndrome (IBS)
Functional Gastrointestinal Disorders (FGIDs)
+4
RECRUITING

NCT06668922

Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin. The target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.

Gender: All

Ages: 18 Years - 75 Years

Updated: 2026-08-12

1 state

Irritable Bowel Syndrome (IBS)
NOT YET RECRUITING

NCT07716852

Enzymax DuoBiotics for Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits in the absence of detectable structural abnormalities. Its pathophysiology is multifactorial and may involve alterations in the intestinal microbiota, impaired epithelial barrier function, low-grade immune activation, and disturbances in the digestion and fermentation of dietary nutrients. Enzymax DuoBiotics combines digestive enzymes with a synbiotic formulation in a capsule-in-capsule delivery system. The outer capsule contains digestive enzymes intended for release in the stomach, whereas the inner capsule contains Lactobacillus plantarum and fructooligosaccharides intended for release in the intestine. This formulation is designed to separate the enzymatic and synbiotic components and support their delivery to the intended gastrointestinal sites. The combined approach is intended to support macronutrient digestion while modulating the intestinal microbial environment. This randomized, double-blind, placebo-controlled, parallel-group study will compare once-daily Enzymax DuoBiotics with placebo over a 12-week treatment period in adults with IBS. Participants will be allocated in a 1:1 ratio, and treatment effects over time will be evaluated using assessments performed during the treatment period. The primary statistical analysis will use linear mixed-effects models including treatment group, time, and the treatment group-by-time interaction. The primary analysis will follow the intention-to-treat principle and may be supplemented by a per-protocol analysis.

Gender: All

Ages: 18 Years - 70 Years

Updated: 2026-07-23

Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS)
NOT YET RECRUITING

NCT07707635

IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome

Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population. Objectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability. Methods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150. Following a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries \[Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)\], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point. Stool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes. Significance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-16

Irritable Bowel Syndrome (IBS)
RECRUITING

NCT07688044

The Role That Food and Bacteria Play in Generating Abdominal Pain

Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat. Our research will explore how a type of dietary carbohydrate, called FODMAPS, contributes to chronic abdominal pain in irritable bowel syndrome (IBS). FODMAPs, are poorly digested carbohydrates and removing FODMAPs from the diet relieves abdominal pain in approximately half of IBS patients. Unfortunately, FODMAPs are contained in many foods, which makes it challenging for patients to remain on a low FODMAP diet for extended periods. Our proposed research will identify which subtypes of FODMAPs are most responsible for increasing pain and will tease apart whether the pain-causing effects of FODMAPs rely on the gut microbiota or not. To identify which specific type of FODMAP causes pain, IBS patients will adopt a low FODMAP diet and then individual FODMAP subtypes will be added back to their diet while monitoring changes to their pain. Stool samples will be collected from the participants to determine whether the composition of the gut microbiota or the chemicals that it produces are changed when symptoms are improved or exacerbated by manipulating FODMAP availability. In parallel studies, the microbiota of each IBS patient will be grown in specialized conditions to mimic the environment of the gut. These patient microbial communities will be exposed to the same FODMAP manipulations as the patients themselves experience. This will allow us to test whether the changes in gut microbiota composition and the chemicals produced that occur in IBS patients in response to FODMAP manipulations also occur when only the microbiota is exposed to these manipulations. Together, these studies will aim to optimize a dietary therapy for a common chronic pain condition and will provide novel insights into how diet affects the chemicals the gut microbiota produces that contribute to abdominal pain.

Gender: All

Ages: 18 Years - 70 Years

Updated: 2026-07-15

1 state

Irritable Bowel Syndrome (IBS)
RECRUITING

NCT07635394

Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).

Gender: All

Ages: 18 Years - 70 Years

Updated: 2026-06-25

1 state

Irritable Bowel Syndrome (IBS)
RECRUITING

NCT04506593

Indiana University Gastrointestinal Motility Diagnosis Registry

Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders

Gender: All

Updated: 2026-06-16

1 state

Eosinophilic Esophagitis
Gastroesophageal Reflux Disease (GERD)
Gastroparesis
+6
RECRUITING

NCT07646834

Anxiety and Depression in IBS: A Brain-Gut Axis Study

This study aims to understand how the gut and the brain communicate in people with Irritable Bowel Syndrome (IBS) who also experience anxiety and depression. We want to see if changes in gut bacteria are linked to changes in brain function, and to find potential markers that could help in diagnosis or future treatments. We are looking for two groups of volunteers aged 18 to 60 years: 1) 100 patients diagnosed with IBS who also have symptoms of anxiety or depression, and 2) 100 healthy volunteers for comparison. All participants must be right-handed. Participants in this observational study will not receive any new drug or treatment. Instead, they will be asked to: Complete questionnaires about their bowel symptoms, anxiety, depression, sleep, and thinking skills. Provide a stool sample (about 5 grams) and a blood sample (about 5 ml). Undergo a brain scan using a 7 Tesla MRI machine, which will take about 45-50 minutes. They will need to lie still during the scan. Some IBS patients may be invited for a follow-up visit after 3 months to repeat the questionnaires and sample collection. There are minimal risks involved. The MRI scan is non-radioactive and considered very safe, but some people may feel uncomfortable or claustrophobic inside the machine. Giving blood may cause brief pain, bruising, or, very rarely, infection. Your privacy is protected. All personal information and data will be coded and kept confidential, and will only be used for this research. The main benefit to participants is receiving a detailed health assessment, including advanced brain imaging and analysis of gut bacteria, at no cost. There is no direct therapeutic benefit from participating, but the knowledge gained may help improve the understanding and future care of IBS.

Gender: All

Ages: 18 Years - 60 Years

Updated: 2026-06-15

1 state

Irritable Bowel Syndrome (IBS)
Anxiety
Depression
ENROLLING BY INVITATION

NCT06657001

Enabling Microbiomics- Driven Personalized Nutrition

The goal of this observational research study is to determine how diet contributes to various gastrointestinal related conditions. The main question investigators aim to answer is: Are host genetics, diet, and microbiome all important determinants of GI disorders, and how their relative contribution varies among individuals and populations.

Gender: All

Ages: 18 Years - Any

Updated: 2026-06-12

1 state

Inflammatory Bowel Disease (IBD)
Irritable Bowel Syndrome (IBS)
Celiac Disease
+7
COMPLETED

NCT07619573

EFFECT OF A DİETİTİAN-SUPERVİSED LOW-FODMAP DİET VERSUS STANDARD WRİTTEN ADVİCE ON GASTROİNTESTİNAL SYMPTOMS AND INFLAMMATORY BİOMARKERS İN IRRİTABLE BOWEL SYNDROME: A RANDOMİZED CONTROLLED TRİAL

Background: Irritable Bowel Syndrome (IBS) is the most prevalent functional gastrointestinal (GI) pathology among GI disorders. Various dietary interventions, particularly the low-FODMAP diet, are employed to alleviate IBS symptoms. Study Population \& Design: This study will include 78 adult patients, aged 18-65, diagnosed with IBS according to Rome IV criteria at the Biruni University Faculty of Medicine Hospital Gastroenterology Outpatient Clinic. Participants will be divided into two parallel groups: Group 1 (n=39): Will receive dietary intervention solely through physician follow-up (provided with a standard hospital brochure listing prohibited foods). Group 2 (n=39): Will receive structured, personalized dietary intervention through individualized nutritional counseling by a dietitian. Duration: The low-FODMAP diet intervention for both groups will last for 8 weeks. Outcome Measures: At baseline (week 0) and at the conclusion of the study (week 8), the following assessments will be conducted: Clinical Scores: IBS Symptom Severity Score (IBS-SSS) and the 15-item Gastrointestinal Symptom Rating Scale (GSRS). Biomarkers: Hs-CRP and fecal calprotectin levels analyzed from blood and stool samples. Objective: The primary objective is to determine the impact of individualized nutritional counseling on GI symptoms and inflammatory biomarkers (hs-CRP, fecal calprotectin) during a low-FODMAP diet. Secondary objectives include evaluating the significance of the dietitian's role and observing how lifestyle factors (sleep and physical activity) influence symptom outcomes alongside nutritional therapy.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-06-02

1 state

Irritable Bowel Syndrome (IBS)
RECRUITING

NCT07584278

Probiotics and Biomarkers in Irritable Bowel Syndrome

The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is: Does the probiotic alter IBS symptom severity? Researchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes. Participants will: Be randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks. Visit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection). Provide biological samples (blood, stool, saliva, urine) Complete questionnaires

Gender: All

Ages: 18 Years - Any

Updated: 2026-06-01

Irritable Bowel Syndrome (IBS)
ENROLLING BY INVITATION

NCT07345377

Study on Treatment Mechanisms and Efficacy Prediction of Individualized Transcranial Magnetic Stimulation in Adults With Irritable Bowel Syndrome Using Multimodal MRI and High-Throughput Sequencing

The goal of this clinical trial is to explore if "individualized repetitive Transcranial Magnetic Stimulation (TMS)" works to improve symptoms in adults with Irritable Bowel Syndrome (IBS). It also aims to learn how this treatment works (by looking at links between the brain, gut, and gut bacteria) and if tests like brain scans or gut bacteria checks can show if the treatment will work for a person. The main questions it aims to answer are: Will individualized TMS improve IBS symptoms (like stomach pain or discomfort) and affect the links between the brain, gut, and gut bacteria? Can brain scan results (from multimodal Magnetic Resonance Imaging, MRI) and gut bacteria checks (from high-throughput sequencing) predict how well a person responds to TMS? Participants will be adults aged 18-59 who: Meet the Rome Ⅳ criteria for IBS (a standard way to diagnose IBS); Have stopped taking IBS-related medicines for more than 2 weeks; Do NOT have MRI or TMS contraindications (like metal implants in the body, mental illness, pregnancy, or serious illnesses requiring hospital stays). Participants will: Receive 10 TMS sessions (5 times a week, for 2 weeks total) - TMS is a non-invasive treatment that uses gentle magnetic pulses on the scalp; Before the first TMS session, and again after the 10th session: Fill out surveys to rate IBS symptoms; Have an MRI scan (painless, takes about 60 minutes) to look at brain activity; Provide a small stool sample to check gut bacteria.

Gender: All

Ages: 18 Years - 75 Years

Updated: 2026-06-01

1 state

Irritable Bowel Syndrome (IBS)
Pain
Depressive Disorder, Major, Moderate
RECRUITING

NCT06940596

Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?

This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.

Gender: All

Ages: 18 Years - Any

Updated: 2026-05-06

1 state

Irritable Bowel Syndrome (IBS)
Intestinal Diseases
Gastrointestinal Disease
WITHDRAWN

NCT05630703

Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet

The study aims to compare the effect of mindfulness-based awareness training in Irritable Bowel Syndrome (IBS) (MB-IBS-EAT) with the dietary standard of care (low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet) on patient's IBS symptoms

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-23

Irritable Bowel Syndrome (IBS)