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NCT06676488
The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.
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.
NCT07337707
Irritable bowel syndrome (IBS) affects around 4% of the general population and remains the most common functional bowel disorder. It is defined by the Rome criteria as the presence of abdominal pain associated with transit disorders. The impact on quality of life and the associated costs make it a public health problem. Visceral hypersensitivity is one of the functional markers of the disease and plays a part in the genesis of symptoms. It could therefore also be a therapeutic target to be explored. Diet and the intestinal microbiota are also part of the recognised pathophysiological mechanisms of this disease. Carbohydrates malabsorbed by the intestine are metabolised by the microbiota, which may contribute to the genesis of symptoms. Among these carbohydrates, fructose appears to be of particular interest. Its absorption capacity is limited, yet fructose consumption is increasing. Fructose malabsorption at a dose of 25 g is present in 22% of IBS patients. Fructose malabsorption is also associated with visceral hypersensitivity. However, the mechanism of this association remains unknown. In models of malabsorbed mice with visceral hypersensitivity, an increase in cholecystokinin was found in the terminal ileum and cecum, suggesting a potential role for this hormone in this model of IBS. However, the underlying mechanism remains poorly understood. The objective is to determine if microbiota signature is specific of visceral hypersensitivity associated with fructose malabsorption in IBS patients. 60 patients with IBS will be included in the study in 4 groups: 1. n=15 patients with visceral hypersensitivity and fructose malabsorption 2. n=15 patients with visceral hypersensitivity and without fructose malabsorption 3. n=15 patients without visceral hypersensitivity and with fructose malabsorption 4. n=15 patients without visceral hypersensitivity and without fructose malabsorption All patients will filled validated questionnaires and 4-days food diary. They will also have a urinary permeability test (lactulose/mannitol test) and collected stools samples for microbiota analysis.
NCT07283341
The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is: 1. What types of food do the kids eat and how do these diets relate to their symptoms? 2. Is there any motility pattern that we can identify from the kids with or without IBS using a wearable patch? 3. What kinds of bacteria and chemicals are found in the gut and urine of children with IBS, and how are these linked to their IBS symptoms? Participants will use the wearable patch, answer questionnaires, collect stool and urine samples, and recall their 24 hours dietary.
NCT06657001
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.
NCT06720805
Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, including diarrhea, constipation, or a combination of both. It is estimated to affect about 10-20% of the global population, with a higher prevalence among children and adolescents. The pathophysiology of IBS is multifactorial and involves alterations in the gut microbiota, visceral hypersensitivity, and abnormal gastrointestinal motility. Probiotics, defined as live microorganisms that provide health benefits when administered in adequate amounts, have emerged as a potential therapeutic option for IBS due to their ability to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects. Several studies have shown the beneficial effects of probiotics in adult IBS patients; however, few studies have been conducted in the pediatric population. Thus, the investigators designed a randomized, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of a 12-week probiotic treatment with a blend of 5 strains of lactic acid bacteria and bifidobacteria in pediatric patients with Irritative Bowel syndrome.
NCT06708533
This intervention study explores whether a routine physical activity intervention can help manage or relieve symptoms of Irritable Bowel Syndrome (IBS) in adults who have been clinically diagnosed with IBS. The main questions it aims to answer is: • Primary Outcome: Does engaging in routine physical activity reduce the severity of IBS symptoms compared to baseline levels? Comparison Group: Researchers will compare the intervention group (receiving the 12-week physical activity program) with a control group (receiving no intervention for 12-weeks). Participant Activities and Interventions: * Complete a 12-week walking programme. * Visit the university on 3 occasions (baseline, week-6 and week-12) for biological sample collection and sub-maximal fitness assessments. * Complete a series of subjective health related questionnaires.
NCT06583395
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.
NCT04506593
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
NCT02092402
The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
NCT03964103
* Primary purpose: To assess satisfaction with overall improvement in symptoms, including individual bowel symptoms, after 4 weeks of administration of gQ-lab to patients with irritable bowel syndrome (IBS). * Secondary purposes: To assess the correlation between intestinal attachment and therapeutic effects of gQ-lab through the visual analog scale (VAS) assessment of each IBS-related symptom and measurement of changes in quality of life and fecal flora in the placebo group and gQ-lab group after 4 weeks of gQ-lab administration. To assess safety, including adverse reactions, vital signs (including weight), physical examination, and changes in blood test results. To examine the rate of positive gut quotient (gQ) values in patients diagnosed with IBS as per the ROME III criteria. Further, to examine how the ROME III-based symptom scale score compared with that of the quality of life scale in the gQ questionnaire.
NCT03550742
This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks. The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.
NCT02841878
Irritable bowel syndrome (IBS) profoundly affects the quality of life. Mucosal micro-inflammation, epithelial permeability disorder and proteases activity increase have been demonstrated in the patients' gastrointestinal tract. Protease activity increase could be subjected to a genetic determinism (decrease in proteases inhibitors genes expression). Objectives: 1/ To study relations between proteases activity (in stool and colonic biopsies supernatants), proteases inhibitors genes expression and mucosal cellular infiltrate (IBS patients and healthy subjects). 2/ Establishing a correlation between proteases activity, mucosal micro-inflammation and symptoms. 3/ To evaluate proteases inhibitors therapeutic potential. Expected results: 1/ Decreased expression of proteases inhibitors genes in subjects with IBS. 2/ Correlation of symptoms with proteases activity intensity. 3/ Demonstration of restorative potential of proteases inhibitors.
NCT02113605
The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.
NCT01774695
Increased physical activity has in the investigators recent study been shown to improve symptoms in irritable bowel syndrome (IBS). The aim of this study was to assess the long term effects of the investigators previous intervention in IBS patients to improve physical activity. The investigators aimed to assess the long term effects on IBS symptoms as well as quality of life, fatigue, depression and anxiety.