Clinical Research Directory

IBS Skin Patch Test Food Allergy Study

Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \"true\" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \"sham\" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own.

Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.

Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)

Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder with a significant impact on the quality of life of patients. Its global prevalence varies considerably, estimated at up to 10%, due to differences in diagnostic criteria, cultural factors and dietary patterns. Dietary interventions have emerged as first-line strategies for symptom management, with the low Fermentable Oligo-, Di-, and Monosaccharides and Polyols (FODMAP) diet demonstrating strong efficacy in reducing gastrointestinal symptoms by minimizing poorly absorbed, fermentable carbohydrates. However, concerns about long-term nutritional adequacy, potential alterations in gut microbiota composition, and sustainability of the low-FODMAP diet have led to the need for more comprehensive and nutritionally balanced dietary models. In contrast, the Mediterranean Diet (MD), is widely recognized for its anti-inflammatory, cardiometabolic, and potential anticancer effects. Notably, adherence to the MD has been associated with favorable gut microbial profiles and a reduced risk of colorectal and other gastrointestinal cancers. However, the high FODMAP content of many components of the MD may limit its direct compatibility with dietary protocols for IBS. Incorporating the principles of the MD into a low-FODMAP dietary approach offers a promising strategy for enhancing the nutritional quality, sustainability, and long-term effectiveness of dietary management in IBS. The aim of the study is to investigate and compare the effectiveness of a Mediterranean Modified Low FODMAP diet (Med-Mod LFD) with standard Mediterranean dietary recommendations (Med standard) in managing the symptoms of IBS. Specifically, the study aims to evaluate the impact of the two dietary interventions on the frequency and severity of gastrointestinal symptoms, to examine potential differences in quality of life, to assess patient compliance and acceptance of the two dietary approaches, and to explore whether the Med-Mod Low FODMAP variation of the Mediterranean diet offers advantages over the classical Mediterranean diet without compromising the health-promoting characteristics that make it beneficial.Dietary intake will also be assessed using a three-day food diary, which will be used for the dietary analysis of participants' food intake and for the assessment of macro- and micronutrient intake of the two dietary interventions

Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

This randomized, double-blind, placebo-controlled trial will evaluate the effects of a 14-day course of rifaximin on bloating symptoms, gut microbiota, microbial metabolites, and intestinal gases in adults with Rome V irritable bowel syndrome with constipation (IBS-C) or functional abdominal bloating (FAB). Participants with predominant, bothersome bloating despite adequate bowel movement management will be randomly assigned in a 1:1 ratio to receive rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with a bloating response, defined as at least a 1-point reduction from baseline on a 7-point Likert bloating scale at the end of treatment. Additional assessments will include other gastrointestinal symptoms, quality of life, psychological symptoms, gut microbiota diversity and composition, fecal short-chain fatty acids, plasma bile acids and gut-derived uremic toxins, and breath hydrogen and methane levels. Associations between biological changes and clinical response will also be examined.

The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain

The proposed pilot study aims to assess the underlying mechanisms of the MBI on IBS pain and the feasibility of using novel technology in the outcome measurements. The specific aims of this pilot mechanistic clinical trial are to: 1. . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles. 2. . evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings. Researchers will conduct a one-arm pre- and post-music intervention among patients with Irritable Bowel Syndrome, collect the IBS pain mechanistic biobehavioral markers, and analyze the underlying pathways of the music analgesic effect. Participants will be asked to: 1. . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week. 2. . have two one-hour lab visits

Effect of Serotonergic Stimulation on the Gut-brain Axis

Selective serotonin reuptake inhibitors increase the level of serotonin. This study will use functional magnetic resonance imaging to examine how subjects with, and without, irritable bowel syndrome patients respond to serotonergic stimulation. Brain activation during emotional and arithmetic tasks and during visceral pain will be measured after serotonergic stimulation using the oral administration of Escitalopram (10 mg). The investigators will further integrate background parameters of the irritable bowel syndrome subjects and healthy controls (such as microbiota composition, genetic markers of serotonergic and inflammatory pathways, intestinal permeability, state of mood and visceral sensitivity) with the responses to the various challenges on the level of functional brain imaging. These responses may reveal a 'footprint' of the individual gut-brain axis function. Analyses of these individual footprints in multiple subjects with and without irritable bowel syndrome may reveal biosignatures characterising certain groups of patients according to specific gut-brain signalling response patterns. These biosignatures may be used to develop an individualised treatment algorithm for irritable bowel syndrome therapy.

IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial

Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. This placebo-controlled interventional study examines person-specific small molecules and bacteria driving IBS and their downstream effects on the human gut epithelium.

Comparison of Rimegepant and Placebo for Pain in IBS

The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 36 weeks.

A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome

Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will assist patients in disease self-management. The Traqq application can provide more detailed information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors are exposed to during the day. The insight provided using ESM and Traqq may improve patient understanding of their personal symptom dynamics and triggers, as well as the physician's insight into the symptom patters of the specific patients, which may aid treatment choice and eventually improve the outcome of any treatment provided in daily clinical care.

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 36 weeks.

Influence of Ear Vagus Nerve Stimulator on Patients With IBS

Irritable bowel syndrome (IBS) is a very common functional digestive disorder characterized by chronic abdominal pain and altered bowel habits in the absence of biological or structural abnormalities. In the field of IBS, effective drug treatments are very limited, and patients are urgently looking for alternatives, including probiotics, hypnotherapy, osteopathy, dietary changes, and fecal microbiota transplants. In recent years, with the continuous elucidation of vagus nerve mechanisms, IBS patients are increasingly interested in bioelectrical regulation, and these patients are often skeptical of traditional drug treatment and believe that drugs are prone to side effects. For several reasons, vagus nerve stimulation (VNS) may be a promising option for improving IBS symptoms. In this experiment, the portable ear nail stimulator produced by Ruishen Medical can accurately stimulate the ear nail, transdermal stimulation of the ear vagus nerve, and give full play to its therapeutic effect. Therefore, the purpose of this clinical trial is to use ear nail stimulator in patients with IBS to explore whether it has therapeutic effects on patients with IBS. To explore the influence of tVNS therapy on irritable bowel syndrome compared with drug therapy, it is hoped that the use of TVNS therapy can reduce the use of related drugs, or even replace drugs. This study intends to recruit a group of patients with irritable bowel syndrome to use the portable ear nail stimulator, (1) to observe whether the symptoms of irritable bowel syndrome patients are improved; (2) To analyze the changes of intestinal microbes in patients with IBS; (3) Verify whether the level of intestinal inflammation is reduced and discover metabolic markers in the intestine.

Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.

A Well-Being Intervention for People With IBS

The purpose of this randomized behavioral clinical trial is to examine whether a well-being intervention can improve both psychological well-being and physical outcomes in adults with Irritable Bowel Syndrome (IBS). The study aims to assess whether this intervention decreases anger, anxiety, and depression; increases self-esteem, empathy, and hope; and improves quality of life indicators such as IBS symptom severity, sleep quality, fatigue, and diet. Participants can expect to be on study for up to 9 months.

A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)

This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.

Short-Term Effects of Low-FODMAP, NICE Dietary Advice, and Intermittent Fasting in Irritable Bowel Syndrome

The goal of this clinical trial is to compare the short-term effects of three dietary approaches in adults with irritable bowel syndrome (IBS): a low-FODMAP diet, adapted National Institute for Health and Care Excellence (NICE) dietary advice, and adapted NICE dietary advice combined with 16:8 intermittent fasting. The main questions this study aims to answer are: How do these three dietary approaches affect IBS symptom severity after two weeks? How do these three dietary approaches affect IBS-related quality of life after two weeks? The researchers hypothesize that the low-FODMAP diet will produce the greatest short-term reduction in IBS symptom severity. The study will also explore whether adding 16:8 intermittent fasting to adapted NICE dietary advice provides additional benefit. Researchers will compare the three dietary groups to determine whether the changes in IBS symptoms and quality of life differ between the dietary approaches. Participants will: Follow one of the three dietary approaches for two weeks. Attend study visits at the beginning of the study, after one week, and after two weeks. Keep records of their food and fluid intake. Complete questionnaires about IBS symptoms, quality of life, anxiety, and depression. Record their stool form and frequency during the study.

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.

Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome

The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.

RELIEF-pathway in Patients With Upper Abdominal Pain

Upper abdominal pain (UAP) is a common symptom and frequently the reason to visit the hospital. The prevalence of epigastric pain in the Dutch population is estimated to be as high as 37%. Moreover, Dutch hospitals yearly record \>100.000 diagnoses related to UAP. In most patients, UAP can be attributed to symptomatic (functional) dyspepsia (FD), Irritable Bowel Syndrome (IBS) or uncomplicated gallstone disease (cholecystolithiasis), with a prevalence in the general population of 20-30%, 20%, and 6-9%, respectively. However, these conditions may have overlapping symptom patterns and generally affect similar populations. which contributes to ineffective (diagnostic) interventions. Patients are generally not aware of the similarity of symptoms and the poor outcome of some treatments. Education positively influences patients' self-management and health judgment. In a recent open-label, multicentre trial the effectiveness of web-based patients' education is applied to reduce overuse of upper gastrointestinal endoscopies in patients with dyspepsia. This study illustrated that an web-based education tool safely reduced 40% in upper gastrointestinal endoscopies. Lifestyle interventions (such as change of diet and/or physical activity) are widely incorporated in treatment programs for cardio-vascular diseases including diabetes mellitus and obesity. An web-based education tool on upper abdominal pain and other complaints combined with a lifestyle interventions for patients may be an effective treatment option for this large group of patients. This study investigates the potential of an individualized web-based education tool as intervention for patients with functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis with the possibility to visit the Prevention and Lifestyle clinic (RELIEF pathway). The RELIEF pathway aims to reduce unnecessary health care utilization and, secondly, to maintain and improve quality of life by educating patients on lifestyle improvement.

GI Alpha-Gal Study

This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.

Antihistamines in the Treatment of Irritable Bowel Syndrome With Diarrhea

Irritable bowel syndrome is a functional disorder of the gastrointestinal tract diagnosed with the Rome criteria. The Rome IV criteria are based on abdominal pain symptoms and stool habits including stool frequency and stool forms \[1\]. They define 3 main subtypes based on symptoms: 1) IBS with diarrhea; 2) IBS with constipation: and 3) mixed symptoms of constipation and diarrhea. The IBS with diarrhea (IBS-D) subtype has the highest prevalence. Currently, treatment of IBS-D includes antidiarrheals, bile acid sequestrants, antispasmodics, tricyclic antidepressants, and FODMAP diet. However, many patients are intolerant or unresponsive to the above treatments. Outside of IBS, chronic diarrhea affects about 5% of adults. We have described a syndrome in a subset of IBS patients presenting with post prandial diarrhea, flushing and dermatographia whose symptoms are prevented by pre-treatment with combined H1 and H2 antihistamines \[2\]. However, the prevalence of this syndrome among the IBS + D patients is not known nor have the clinical characteristics or predictors of antihistamine responsive IBS + D been defined.

Low-FODMAP vs Gluten-Free Diet in Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and irregular bowel habits. Dietary interventions, particularly low-FODMAP and gluten-free diets, have gained increasing interest in IBS management. However, comparative data on these two approaches remain limited across different populations, including the Turkish population. This study was designed to compare the effectiveness of a 4-week low-FODMAP diet versus a gluten-free diet on gastrointestinal symptoms in Turkish patients with IBS. A total of 70 patients diagnosed with IBS according to Rome IV criteria were enrolled in this prospective, controlled, parallel-group clinical trial. Patients were sequentially assigned to either the low-FODMAP group (n=35) or the gluten-free diet group (n=35). Both dietary interventions were implemented over 4 weeks under the guidance of an experienced dietitian, with weekly telephone follow-ups to monitor dietary compliance. Gastrointestinal symptoms were evaluated at baseline and at the end of the intervention using the Gastrointestinal Symptom Rating Scale (GSRS).

Efficacy of Esketamine for Patients With Irritable Bowel Syndrome

To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

Dietary Interventions for Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by recurrent abdominal pain and altered bowel habits. Dietary factors may trigger or worsen symptoms such as abdominal pain, bloating, gas, diarrhea, and constipation. This study evaluated and compared the effects of a low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP) diet and a combined gluten-free and lactose-free diet on symptom severity in adults diagnosed with IBS. Adults aged 19-64 years with IBS followed one of the two dietary interventions for six weeks. IBS symptom severity was assessed at baseline and at the end of week 6 using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). Dietary adherence was monitored by telephone during the intervention.