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Irritable Bowel Syndrome clinical trials

View clinical trials related to Irritable Bowel Syndrome.

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NCT ID: NCT06261320 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

Mesotherapy Treatment of Irritable Bowel Syndrome

MESOCOLO
Start date: February 28, 2024
Phase: Phase 2
Study type: Interventional

Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems. Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy. Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms.

NCT ID: NCT06124313 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health

Start date: September 14, 2023
Phase: N/A
Study type: Interventional

This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.

NCT ID: NCT05379036 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome

Start date: June 23, 2021
Phase: Phase 4
Study type: Interventional

Patients with diarrhea-predominant irritable bowel syndrome (IBS) and functional dyspepsia (FD) were examined and received treatment in the study. Severity of complaints and quality of life patients were assessed according to questionnaires. The state of the intestinal barrier (analysis of the protein composition, intestinal mucin levels in biopsies, serum zonulin level in blood), the composition of the gut microbiota (16S rRNA gene sequencing), bacterial metabolic function (short-chain fatty acid levels in feces), and the presence of gut inflammation (levels of lymphocytes and eosinophils in biopsies) were assessed in the patients. Patients were divided into 3 treatment groups: trimebutin + placebo, rebamipide + placebo, trimebutin + rebamipide. The above parameters were compared in patients before and after treatment.

NCT ID: NCT05307185 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Tritordeum-based Foods for IBS Symptoms

TritoinIBS
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

People with irritable bowel syndrome (IBS), especially those with diarrhea (IBS-D), often describe worsening symptoms after eating certain foods. A structured dietary approach may represent a reliable strategy to improve their symptoms. In this framework, the diet low in oligosaccharides, disaccharides, monosaccharides, and fermentable polyols (FODMAPs - LFD) has been demonstrated to mitigate symptoms and reduce inflammatory status, increase vitamin D content, and affect the lipidomic profile. Unfortunately, adherence to LFD can be somewhat problematic, needing continuous nutritional support. Other dietary approaches with putative beneficial effects have been proposed to overcome these limitations. Among them, Tritordeum-based foods (TBD, bread, bakery products, and pasta) in substitution of other cereals seem to achieve promising results. TBD may represent a valid alternative, with high palatability, especially among Italian patients for whom pasta is considered one of the main assets of dietetic culture and easier to manage in their daily habits. Given these premises, this study aims to evaluate, in a randomized single-blinded controlled trial, the effects of 12-weeks of TBD compared with LFD and dietary advice of the same duration in improving the symptom profile well as the intestinal permeability and reducing putative dysbiosis of IBS-D patients. Along with the clinical study, an evaluation of gluten and proteomic composition will be performed to examine more in detail the intrinsic characteristics of Tritordeum.

NCT ID: NCT05118243 Active, not recruiting - Clinical trials for IBS - Irritable Bowel Syndrome

Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance

LeguComf
Start date: September 6, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of enzymatic treatment to reduce GOS (galactooligosaccharides) in legume-based crackers in IBS (irritable bowel syndrome) persons. The crackers are pea-based: the control crackers contain high amounts of GOS, while the enzymatically treated crackers contain a minimal amount of GOS. The participants will eat each type of cracker for three days (daily dose of 12 crackers) and report their gut symptoms (e.g. flatulence, stomach pain, bloating) by using a mobile app. There is a washout period of four days between the different crackers. In addition, the participants will keep food records on the cracker eating days as well as collect five fecal samples during the study. The participants will also report their physical activity and the number of defecations on each day. The study is carried out in a double-blinded crossover setting.

NCT ID: NCT05056610 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Confocal Laser Endomicroscopy to Determine Influence of Food Antigens on Mucosal Integrity

RDS_CLE
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is mainly associated with food intolerance and presents a particular challenge in gastrointestinal practice. The clinical symptoms are often associated by patients with the consumption of certain foods. This leads to strict elimination diets, and often without identification of the triggering food. In particular, the avoidance of wheat yields a relief of the clinical symptoms in many patients. Nevertheless, it is unclear which components of wheat are responsible for the symptoms. Besides the glutens, other wheat proteins, such as the amylase trypsin inhibitors, but also carbohydrates are discussed as triggers of the diseases. Confocal laser endomicroscopy (CLE) is a new diagnostic method for detecting the local effect of food on the mucosa. CLE enables microscopic assessment of the mucosa already during an endoscopic examination and also allows statements to be made about intestinal permeability through changes in the influx of fluorescein into the intestinal lumen. In the course of the study, diluted food solutions are applied to the mucosa after a detailed assessment of the mucosa via the endoscope. The changes in mucosa and permeability are observed and documented. Tissue samples are then taken for histopathological assessment of the degree of inflammation. Further biopsies are taken and cultured in vitro to produce human organoids. The organoids are stimulated with the food. Changes in proliferation, gene and cytokine expression are determined. The aim of the proposed project is to investigate the influence of the main allergens, e.g. wheat, soy, milk, yeast and chicken egg white on the intestinal mucosa. The data obtained will be compared with the histopathological findings and the in vitro data in the human organoid model. The long-term goal is to establish a valid patient-based rapid detection method for the detection of the triggering substances in patients with IBS or food intolerances.

NCT ID: NCT05042661 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation.

NCT ID: NCT04899869 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

MISCEAT
Start date: June 17, 2021
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.

NCT ID: NCT04723056 Active, not recruiting - Clinical trials for IBS - Irritable Bowel Syndrome

Zemedy Application for Irritable Bowel Syndrome

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is investigate the effectiveness of Zemedy, a mobile application that enables the digital delivery of a CBT program to people with IBS.

NCT ID: NCT04691544 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Start date: May 5, 2021
Phase: Phase 3
Study type: Interventional

Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood. The next disruptive frontier would be to find a cure where the effect is predictable and lasting. The study groups phase 2 pilot trial was the first indication of a possible benefit from treating IBS with fecal microbiota transplantation (FMT) (Number needed to treat only five) (Fecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomized, placebo-controlled, parallel-group, single-centre trial he Lancet Gastroenterology and Hepatology 2018). Additional results from the same trial show that the treatment response may be predicted (unpublished data), and that the pathophysiologic mechanisms behind the treatment response also can be identified (Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome, Gut Microbes 2020). This study is the first phase 3 trial of FMT for IBS worldwide. The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS, with little adverse events or complications. Patients ≥18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized, placebo controlled, parallell-group multi center trial. Participants are randomized to FMT from a healthy donor (intervention group), or their own feces (placebo group). The primary outcome is the proportion of patients with ≥75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment.