Clinical Research Directory

Effect of Abdominal Massage on Gastrointestinal Symptoms After Head and Neck Cancer Surgery

This study aimed to evaluate whether abdominal massage could reduce abdominal pain, constipation, and gas/bloating in patients receiving enteral nutrition through a nasogastric tube after surgery for head and neck cancer. A total of 70 patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups. The intervention group (35 patients) received abdominal massage for 15 minutes twice daily over three consecutive postoperative days, in addition to routine nursing care. The control group (35 patients) received routine nursing care without abdominal massage. Abdominal pain, constipation, and gas/bloating were assessed using standardized measurement tools. Assessments were performed twice daily, in the morning and evening, during the first three postoperative days. The study was conducted to investigate whether abdominal massage could be a useful non-drug nursing intervention for managing gastrointestinal symptoms in patients recovering from head and neck cancer surgery.

A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults

This study aims to investigate the effect of two digestive enzyme dietary supplements, THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases in supporting the breakdown of fat after a meal. The first dietary supplement, THRIVE4U™ TG Lipase, contains a single lipase while the other, THRIVE4U™ Spectrum Lipases, contains a blend of lipases. Lipase breaks down fats to allow your body to efficiently absorb it from food. Poor digestion of fat can cause gastrointestinal symptoms and can impact quality of life. By improving the digestion of fats from high-fat foods, the lipase(s) may help reduce discomfort and support overall digestive health.

Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis

This study is a double-blind, randomized, placebo-controlled study that evaluates the safety and tolerability of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to evaluate the safety and tolerability of the supplement, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fibers impact on gastrointestinal symptoms and quality of life through the use of custom questionnaires built for the study population and evaluation of other endometriosis related parameters such as pelvic discomfort. Exploratory objectives focus on the exploration of the gut and vaginal microbiomes, their connection to endometriosis, and how they are impacted by the study product.

IgG Binding Protein LT in Support of a Healthy Gut on the Go

PS52 is a randomized, double-blind, placebo-controlled, fully decentralized study sponsored by Bactolife A/S and conducted by People Science, Inc. It evaluates whether IgG Binding Protein LT (BP-LT), supports gut health in healthy US adults aged 18-70 travelling 7-21 days to Africa, Asia or Latin America/Caribbean countries. Participants are randomized 1:1 to BP-LT (one 75 mg capsule twice daily with food, 150 mg/day) or a matching placebo for the length of their trip. The primary endpoint is the change in GSRS total score from Baseline to End-of-Study versus placebo. Secondary endpoints cover stool frequency and consistency, gut microbiome and inflammation markers, appetite, cognitive function, safety, and outcomes in travellers who test positive for E. coli. Part 1 enrols 100-250 participants, and an interim analysis may expand the study to a maximum of 800 participants.

Probiotic and Prebiotic Use in Early Postoperative Period of Sleeve Gastrectomy

This randomized controlled clinical study investigates the effects of daily synbiotic supplementation (containing Lactobacillus rhamnosus GG and partially hydrolyzed guar gum) in patients who underwent sleeve gastrectomy. 60 participants aged 18-65 with a BMI of 35 or higher were randomly assigned to intervention (n=30) and control (n=30) groups. The intervention group received a 5 g sachet daily for 12 weeks postoperatively, mixed into 200 ml of yogurt and consumed during afternoon snacks. The control group received no supplementation. Anthropometric measurements, biochemical parameters, and gastrointestinal outcomes were assessed at baseline, week 4, and week 12. The aim is to evaluate the influence of probiotic and prebiotic supplementation on gastrointestinal function and biochemical markers in the early postoperative period following bariatric surgery.

Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience

Bacteriophages are viruses that can selectively infect specific species and strains of bacteria. Some bacterial species in the human gut have been negatively associated with gut health and skin health. This study is designed to measure the efficacy of two different bacteriophage-based treatments for 4 weeks to improve gut and skin health. These treatments are bacteriophage that target specific strains of Escherichia coli and Staphylococcus Aureus.

Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section

Cesarean section is a common surgical procedure performed to deliver a baby when vaginal birth may pose risks to the mother or infant. Although it is often life-saving, recovery after cesarean section is frequently associated with multiple physical and psychological challenges, including postoperative pain, delayed gastrointestinal function, reduced mobility, fatigue, and decreased overall well-being. These factors may negatively affect a woman's ability to care for her newborn, initiate breastfeeding, and adapt to the postpartum period. In recent years, there has been increasing interest in non-pharmacological interventions that can safely support postoperative recovery without causing additional side effects. Among these, music therapy, breathing exercises, and virtual reality applications have been identified as promising approaches. Music therapy may promote relaxation and reduce pain and anxiety through auditory stimulation and emotional regulation. Breathing exercises may enhance parasympathetic activity, improve oxygenation, reduce stress, and support gastrointestinal motility. Virtual reality applications, by providing immersive audiovisual experiences, may reduce pain perception, decrease anxiety, and improve overall comfort through distraction and relaxation mechanisms. Although these interventions have individually demonstrated beneficial effects in postoperative care, the existing literature is limited in directly comparing their relative effectiveness within the same study design. Furthermore, most studies have primarily focused on pain outcomes, while other important aspects of recovery, such as obstetric recovery quality and gastrointestinal symptoms, have received less attention. This randomized controlled trial aims to comparatively investigate the effects of music therapy, breathing exercises, and virtual reality application on obstetric recovery, pain, and gastrointestinal symptoms in women following cesarean section. Participants will be randomly assigned to one of three intervention groups or a control group receiving routine care. Standardized protocols will be applied for each intervention to ensure consistency. The primary outcomes of this study include obstetric recovery, pain intensity, and gastrointestinal symptoms. By evaluating these outcomes simultaneously, the study aims to provide a more comprehensive understanding of post-cesarean recovery. The findings of this study are expected to contribute to evidence-based clinical practice by identifying effective, safe, and feasible non-pharmacological interventions that can be integrated into routine post-cesarean care. Ultimately, this research may help improve maternal comfort, accelerate recovery, and enhance the overall postpartum experience for women undergoing cesarean section.

Effects of Synbiotic Supplementation on Gastrointestinal Symptoms, Appetite, and Nutritional Recovery in Patients After Autologous Bone Marrow Transplant

Patients undergoing autologous bone marrow transplantation (ABMT) receive high-dose chemotherapy and routine prophylactic antibiotics, which often disrupt the gut microbiome (dysbiosis). This imbalance can lead to debilitating gastrointestinal complications, loss of appetite, decreased dietary intake, and malnutrition, impairing recovery. The purpose of this randomized controlled trial is to evaluate whether daily supplementation with a tri-component synbiotic (combining multispecies probiotics, xylo-oligosaccharide prebiotics, and a tributyrin postbiotic) can improve gastrointestinal symptoms, appetite, and nutritional status in adult hematological cancer patients following autologous bone marrow transplantation. Participants will be randomly assigned (1:1 ratio) to either: 1. Control Group: Receiving standard post-transplant nutritional care based on clinical guidelines. 2. Intervention Group: Receiving the same standard nutritional care plus a daily oral synbiotic capsule for 3 months. Participants will be followed during the 3-month intervention period and for an additional 1-month post-intervention follow-up phase to assess the sustainability of benefits. The study will evaluate digestive symptoms, self-reported appetite, dietary intake, body weight, inflammatory markers (fecal calprotectin), and protein status (serum albumin), while closely monitoring participant safety.

A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women

The goal of this clinical trial is to investigate the safety and efficacy of Bloat on postprandial bloating in healthy women. The main question it aims to answer is what is the difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo for 55 days, and answer questionnaires on gas, bloating, and abdominal discomfort/distension.

Final Examination Stress and Bowel Symptoms

This prospective observational study aims to investigate the association between final examination stress and bowel symptoms in university students. Participants will be evaluated during the final examination period, which represents a naturally occurring period of increased academic stress. Bowel-related symptoms, including constipation-related complaints, defecation-related pain, stool characteristics, and urgency, will be assessed. Participants will also complete a 7-day diary to record bowel characteristics and selected lifestyle factors, including sleep duration, daily step count, and fluid intake. These factors will be examined as potential variables associated with bowel symptoms during the examination period.

Intermediate Wheatgrass Products and Gut Health

This study will evaluate the effect of daily consumption of intermediate wheatgrass-based products on measures of gut health compared with whole wheat-based products in healthy adults with traditional western fiber intake. Participants will first complete screening, stool sample collection, and the Diet History Questionnaire III. Participants with dietary fiber intake greater than 12g/1000 calories per day will complete the study after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will enter a randomized crossover dietary intervention. During the intervention, participants will consume intermediate wheatgrass-based products and whole wheat-based products in randomized order. Each intervention period will last 2 weeks and will be separated by a 2-week washout period. The primary outcome is change in Gut Microbiome Wellness Index. Gastrointestinal symptom scores will also be assessed.

Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder

This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann. Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology \& Microbiology of Baylor College of Medicine.

Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

Gastroscopy is a key diagnostic approach for upper gastrointestinal diseases, but pharyngeal passage of the gastroscopy often causes participants' discomfort. Topical pharyngeal anesthetics are routinely used to alleviate such discomfort. Dyclonine hydrochloride mucilage and tetracaine hydrochloride jelly are the two most commonly used topical pharyngeal anesthetics in clinical practice. Although both agents are widely used, their comparative efficacy in unsedated gastroscopy remains unclear, and high-quality evidence is scarce. This study aims to compare their anesthetic efficacy,participant comfort, and safety.

Mechanisms of Gulf War Illness

Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans. Our proposed studies will provide an innovative and novel treatment trial for chronic gastrointestinal symptoms in veterans with Gulf War Illness that were deployed into war zones. Given that there are currently no specific treatments for these disorders, and that current symptomatic approaches are far from ideal, proof of principle of our trial would be an extremely important advance as it would not only have a beneficial impact on the health of many thousands of our veterans, but also it would substantially reduce the many negative economic effects of this ailment on the VA Health Care System.

A Study to Evaluate the Effects of a Fiber Supplement on Gut Health

This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of BelliWelli Daily Fiber + Probiotics supplement on gut health over 12 weeks. One hundred participants with self-reported gut health issues will be randomized to receive either the active fiber supplement or a matched placebo product, taken twice daily. Participants will complete questionnaires and provide waist and body composition measurements at Baseline, Week 4, Week 8, and Week 12. The primary outcomes include changes in overall gut health scores, waist circumference, and body composition. Secondary outcomes include participant-perceived effects on bloating, regularity, hydration, energy, and hair, skin, and nail support.

A Clinical Trial to Evaluate the Effects of Super Liver Liquid Drops on Gut Health, Digestive Comfort, and Daily Energy Levels

This is a decentralized (fully virtual), single-group, open-label, prospective clinical trial evaluating the effects of Super Liver Liquid Drops, a liquid botanical dietary supplement, on gut health, digestive comfort, energy levels, and overall well-being over 12 weeks. All 35 enrolled participants will self-administer 2 mL of Super Liver Liquid Drops daily (2 droppers filled to 1 mL each) in the morning with breakfast for the full 12-week intervention period. Participants will complete validated questionnaires and self-reported assessments at Baseline, Week 2, Week 4, Week 8, and Week 12 via the Citruslabs study platform. All study activities will be conducted remotely.

Foot Reflexology and Acupressure on Gastrointestinal Symptoms

This research was planned to evaluate the effects of foot reflexology and acupressure applications on gastrointestinal symptoms in women going through menopause. Menopause is a period in which a woman experiences profound changes in her physiological, psychological, and social life due to the decrease in estrogen and progesterone hormones. Changes in digestive system functions are particularly common during this period; gastrointestinal symptoms such as constipation, bloating, heartburn, indigestion, and abdominal pain significantly reduce the quality of life. The scope of the study focuses on investigating the manageability of these symptoms that occur during menopause with reflexology and acupressure, which are complementary and alternative medicine methods. Reflexology is a method based on the assumption that specific points on the soles of the feet are connected to the relevant organs in the body, aiming to increase blood circulation and regulate organ functions. Acupressure, based on Chinese medicine, aims to regulate energy flow and reduce symptoms by applying finger pressure to specific acupuncture points. Both methods are increasingly recommended for symptom management during menopause due to their non-invasive nature, low side effects, and ease of application. This research will be conducted at Osmaniye State Hospital and will be limited to menopausal women who apply to this institution. Participants' demographic characteristics, duration of menopause, health history, and gastrointestinal symptom levels will be assessed using a Demographic Information Form and the Gastrointestinal Symptom Rating Scale (GSRS). The application process will be carried out in accordance with standard reflexology and acupressure protocols, and changes in symptoms will be analyzed using pre-test and post-test measurements. The study also aims to reveal the effects of gastrointestinal symptoms experienced during menopause on women's quality of life; This study aims to provide evidence-based data on complementary methods that can be integrated into nursing care, in addition to pharmacological treatments. The limited number of studies in the literature addressing the effects of complementary medicine practices during menopause makes this research unique from both a clinical and academic perspective.

The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers

The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\[s\] it aims to answer \[is/are\]: Does Humiome ® Post LB improve bowel movements with self-reported GI issues? Participants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.

GutCheck: Optimization of a Personalized Mobile Health App for Survivors of Gastrointestinal Cancer

There are two components to the study: a patient and a clinician study. The clinician study will include one-hour semi-structured interviews with oncology specialists to identify facilitators and barriers to integrating digital diet interventions into the clinical workflow, and to understand their needs and preferences for digital diet interventions. The patient study aims to investigate initial feasibility, efficacy and acceptability of the GutCheck app and intervention. It will last 9 weeks and involves 2 study visits and 2 active phases with a transition week and optional transition visit between phases. During active phases, participants will be asked to use the GutCheck app every day. Prior to the first active phase, participants will go through informed consent and app training. The first active phase will last two weeks and will focus on tracking participants' diet, gastrointestinal (GI) symptoms, and stress. The data collected during the first active phase will be used to identify any potential trigger foods that may contribute to GI symptoms, but only if the participant reports experiencing GI symptoms. Between active phases, participants will have one Transition Week, where results from the first phase are given to the participants with the option to attend a Transition Week Visit. The second active phase will last four weeks and will involve the message intervention. A single-blind, micro-randomized trial design will be used to repeatedly randomize participants to different intervention combinations, determining both the timing and frequency of intervention message delivery throughout the day. Lastly, there will be an exit visit and interview within a week from the intervention to collect post-intervention measures and ask about the participant's experience with the GutCheck app.

Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management

This study aims to evaluate the changes in metabolic parameters, intestinal permeability, and gastrointestinal symptoms in individuals who have undergone bariatric surgery (Laparoscopic Sleeve Gastrectomy - LSG) for obesity treatment. Obesity is a chronic disease associated with serious health complications including type 2 diabetes, hypertension, cardiovascular disease, and metabolic disorders. Bariatric surgery is currently the most effective treatment method for morbid obesity. However, monitoring patients after surgery in terms of metabolic health, gut permeability, and gastrointestinal symptoms is crucial for long-term success. In this study, 40 volunteers (aged 19-50) who have undergone LSG surgery within the last month will be followed for 6 months. At the beginning of the study and 6 months later, the following will be assessed: * Metabolic parameters: fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels * Intestinal permeability markers: zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels * Gastrointestinal symptoms: assessed using the Gastrointestinal Symptom Rating Scale (GSRS) * Anthropometric measurements: body weight, height, waist and hip circumference, BMI * Nutritional intake: 3-day dietary records The study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic. Results will contribute to understanding the relationship between bariatric surgery and gut health, potentially helping to prevent postoperative complications.

Gastrointestinal Health Survey of Dalian College Students

This is a cross-sectional study aimed to investigate the current status of gastrointestinal health among full-time undergraduate students aged 18-25 years in Dalian, and to clarify the influences of factors such as diet, sleep, psychological mood, and antibiotic use on gastrointestinal symptoms, as well as gender differences. The study plans to enroll 1020 eligible college students and collect information including demographics, gastrointestinal symptoms in the past month, lifestyle, and medication use. Statistical analyses will be performed using the chi-square test, Mann-Whitney U test, Spearman correlation analysis, and multivariate logistic regression. The primary objective is to assess the prevalence and distribution characteristics of gastrointestinal discomfort among college students; the secondary objectives are to identify independent risk factors and analyze gender differences. The results of this study will provide data support for colleges and universities to carry out gastrointestinal health education, schedule and dietary interventions, and rational medication guidance, as well as evidence-based basis for improving digestive health in young populations.

The Effects of Postbiotic Supplementation in Female Athletes

The goal of this clinical trial is to learn if a postbiotic supplement can reduce stomach and gut symptoms in physically active women. The main questions it aims to answer are: Does the supplement reduce gut symptoms during the menstrual cycle? Does it improve symptoms related to exercise? Researchers will compare the postbiotic supplement to a placebo (a look-alike capsule that contains no active ingredient) to see if the supplement works. Participants will be physically active, premenopausal female athletes. Participants will: Take either the postbiotic supplement or a placebo each day for two menstrual cycles Track their menstrual cycle and training Report gut symptoms using regular questionnaires Provide stool samples to assess gut health This study will help researchers understand whether postbiotic supplements can improve gut health and reduce symptoms that may affect training and performance in female athletes.

Impact of Dietary Fibre Supplementation on Gut Symptoms in Healthy Participants

Fibres found in food are mainly carbohydrates that are not broken down or absorbed during human digestion but instead pass to the colon to be fermented by microbes. Gases produced during bacterial fermentation (hydrogen, methane, and carbon dioxide), can cause unpleasant gastrointestinal symptoms in some individuals, such as bloating, flatulence, and stomach pain. Gas production varies between individuals and is influenced by the chemical structure of dietary fibres, the gut microbes' ability to ferment fibre, intestinal pH, and the transit time of intestinal contents. This randomized clinical trial in healthy adults will investigate how individual variations in the microbiome influence the level of gastrointestinal (GI) symptoms induced by different fibre types during short-term exposure.

The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight

The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic. The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.