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Showing 1-20 of 190 trials
NCT07481422
The goal of this clinical trial is to learn if oral capsules containing lyophilized fecal microbiota transplantation (FMT) can safely and effectively treat refractory irritable bowel syndrome (IBS) in adults aged 18-65 years. The main questions it aims to answer are: Does treatment with lyophilized FMT capsules reduce IBS symptom severity compared with placebo? Does treatment with lyophilized FMT capsules improve quality of life, anxiety, and depression in patients with IBS? Are there differences in the frequency of adverse events between participants receiving FMT capsules and those receiving placebo? Researchers will compare lyophilized FMT capsules to placebo capsules to see if FMT reduces IBS symptoms and improves quality of life and mental health. Participants will: Be randomly assigned to receive either lyophilized FMT capsules or placebo capsules for three consecutive days. Take the capsules under supervision after receiving a proton pump inhibitor before the first dose. Complete questionnaires assessing symptom severity, quality of life, anxiety, and depression at baseline, 4 weeks, and 12 weeks after treatment. Attend follow-up visits at 4 weeks and 12 weeks after treatment and receive a telephone follow-up call 10 days after capsule ingestion. Report any adverse events and have vital signs and medical information monitored during follow-up. This study will help determine whether oral lyophilized FMT capsules are a safe and effective treatment option for adults with refractory IBS.
NCT07471490
This study will evaluate how well the a new stool test can distinguish inflammatory bowel disease (IBD) from non-IBD conditions compared with standard calprotectin testing and colonoscopy findings. Participants will undergo only routine clinical care, including colonoscopy, and will provide a stool sample for testing. The study will also examine how test results relate to endoscopic, histologic, and ultrasound measures of disease activity. Findings may help determine whether the new test could reduce unnecessary colonoscopies and support future regulatory submissions.
NCT05740319
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
NCT04598295
This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with constipation. 50 IBS-C or IBS-M patients will receive DS-01 (Daily Synbiotic, once daily) for 12 weeks, while 50 IBS-C or IBS-M patients will receive the placebo (once daily). Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects will also receive extensive education on use of the synbiotic.
NCT07089420
This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS). In this study, healthy volunteers aged 22 and older will collect a stool sample at home using a simple kit and mail it to the study site. The samples will be tested using a new laboratory method called the ALPCO Calprotectin CLIA assay. The goal is to confirm what level of calprotectin is considered "normal" in people without intestinal disease. Participation involves just one stool sample, and there are no medical procedures. Volunteers will be compensated for their time. The study will help improve how doctors interpret calprotectin test results in clinical settings.
NCT06866106
The purpose of this study is to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.
NCT03729271
The purpose of this study is to learn more about how to improve treatment of patients with diarrhea predominant Irritable Bowel Syndrome (IBS-D) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study.
NCT06297785
Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity. Secondary outcomes are GI-specific anxiety, general anxiety and depression, quality of life, and extracolonic symptom severity. Usability of the digital platform as well as patient treatment satisfaction will also be assessed.
NCT07309601
The goal of this interventional study is to examine whether those patients with irritable bowel syndrome (IBS) and a reduced abitility do degrade starch and sugar (lowe levels of enzymes) have lower raise in blood glucose after a meal than those with normal expression of enzymes. We also want to examine whether those IBS patients with reduced enzyme levels have increased bowel symptom in relation to this meal. The main questions it aims to answer are: Does reduced ability to degrade starch and sugar due to less enzyme activity lead to lower increase in blood glucose after a meal? Does reduced ability to degrade starch and sugar due to less enzyme activity lead to increased bowel symptoms after a meal?
NCT05293769
During an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. Dietary intake will be assessed by a newly developed food frequency questionnaire (FFQ) and a 4 days food diary. In order to validate the FFQ in different populations, participants will be recruited from university students, staff of UZ Brussel and VUB, and from the community by advertisement (including social media). IBS patients will be recruited from the gastro-enterology outpatient clinic.
NCT04665271
The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.
NCT06687616
Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a virtual reality (VR) cognitive behavioral therapy (CBT) program versus sham VR among patients with irritable bowel syndrome (IBS). It is hypothesized that using VR-administered CBT may reduce abdominal pain, leading to improved overall physical, psychological, and social functioning when compared to sham VR.
NCT06727422
The purpose of this study is to examine the effectiveness of using a combination of a drug, rifaximin and a dietary supplement, N-acetyl-L-cysteine (NAC), to treat patients with irritable bowel syndrome with diarrhea (IBS-D). Rifaximin is one of the standard treatments for IBS-D and is FDA approved. While rifaximin is safe and effective for treating symptoms in patients with IBS-D, many patients find that their symptoms may not completely resolve, or may come back after a period of time. This research study is designed to test the investigational use of a combination of rifaximin and NAC. The combination of rifaximin and NAC is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS-D, and the effects of taking both medications together are unknown. However, the two medications are approved for use separately, as detailed below. Rifaximin is the only antibiotic approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 550 mg by mouth three times daily for 14 days) is approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 200 mg per mouth three times daily for 3 days) is FDA approved for the treatment of traveler's diarrhea. Rifaximin at a dose of 200 mg per mouth three times daily is not approved by the FDA for the treatment of IBS-D. NAC is approved by the FDA to treat acetaminophen overdose (72-hour oral and 21-hour intravenous (IV) regimens), and for use in breaking up mucus in the lungs in patients with chronic obstructive pulmonary disease (COPD) and other lung conditions such as bronchitis. NAC is also available over-the-counter in 600 mg and 900 mg capsules as a dietary supplement, although over-the-counter use is not regulated by the FDA. This study will utilize the 600 mg dietary supplement capsules. The Investigators want to know if using a combination of rifaximin and NAC will give better results in decreasing IBS-D symptoms than using rifaximin alone. As NAC is used to break up mucus in the lungs, and the Investigators want to see if this can also break up the mucus layer in the small intestine, and therefore potentially increase the effectiveness of rifaximin. The Investigators will be testing 2 doses to determine which dose is most effective. participants are being asked to take part in this research study because participants were diagnosed with IBS-D.
NCT03869372
This is an exploratory neurophysiological study that will determine the impact of non-invasive brain stimulation on autonomic regulation, with a focus on gastrointestinal function. These studies should provide a basis for future brain-based neurotherapeutic strategies in patients with functional GI disorders.
NCT03823742
The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a specific child would benefit most from CBT or from the low FODMAPs diet.
NCT03339128
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.
NCT07103772
Irritable bowel syndrome is characterized by the presence of chronic, recurrent abdominal pain, alterations in bowel habits, and abdominal distension. The medical diagnosis is made using the Rome IV criteria. There are three IBS phenotypes: diarrhea-predominant, constipation-predominant, and mixed.
NCT03678935
The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.
NCT03223077
Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are doing this study to understand if changes in gut bacteria and gut mucosal lining during an acute infection can help identify individuals who might be at risk for developing problems in the future.
NCT06960941
The term "inflammaging" describes the aging process characterized by a chronic low-grade inflammatory state. With advancing age, this condition is often associated with cardiovascular disease, diabetes, and neurodegenerative diseases. Often, the inflammaging state is characterized by environmental factors, such as pollution, diet, and physical inactivity, as well as the accumulation of free radicals and alteration of the gut microbiota. Inflammaging also appears to be linked to irritable bowel syndrome (IBS), a functional gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, and is related to low-grade mucosal inflammation, which may contribute to visceral hypersensitivity and symptom severity.In addition, cytokine activity and alterations in intestinal immune cells would appear to participate significantly in the pathogenesis of IBS. Additionally, there is an independent correlation between IBS and a higher prevalence of metabolic syndrome. Given the multifactorial nature of IBS, no effective treatment has been identified to date. However, considering the central role that alteration of the gut microbiota plays in IBS, the use of prebiotics and probiotics may represent an alternative therapy, as well as help in managing the inflammatory state. Probiotics are live organisms present in the intestinal tract that have the ability to resist the action of digestive enzymes.