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Colitis, Microscopic clinical trials

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NCT ID: NCT06172647 Recruiting - Colorectal Cancer Clinical Trials

Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer

CMBACT
Start date: June 1, 2022
Phase:
Study type: Observational

Microscopic colitis (MC) is an inflammatory bowel disease characterized by chronic non-bloody watery diarrhoea and a macroscopically normal colonic mucosa upon endoscopic exploration (colonoscopy). The diagnosis is performed by microscopic examination of mucosal biopsies that reveal specific histopathological change. Between 4-20% of patients with chronic non-bloody diarrhoea who undergo colonoscopy with serial biopsies are diagnosed with MC. It has long been hypothesized that the microbiome plays a key role in the pathogenesis of MC. In patients with collagenous colitis, faecal stream diversion results in inflammation and histological remission, followed by disease relapse after intestinal transit is reconstructed. Moreover, studies carried out with faecal samples obtained after colonoscopy have demonstrated microbiome changes (reduced alpha diversity and higher microbial dysbiosis index) in patients with active MC. To avoid potential bias due to the effect of colonic lavage prior to colonoscopy in microbiota composition, the researchers of the present study previously evaluated the microbiome in faecal samples obtained before the diagnostic colonoscopy in patients with active MC. The results confirmed a reduced alpha diversity in diarrhoea groups; however, there were no differences between MC, bile-acid diarrhoea and functional diarrhoea. The microbial dysbiosis index was significantly higher in MC compared to the other diarrheal groups, but no bacterial species showed a significantly different relative abundance. On the other hand, the risk of colorectal cancer (CRC) or adenoma seems to be reduced in MC compared to controls. Growing evidence suggests microbial dysbiosis is a crucial environmental factor in the initiation of precancerous lesions of CRC such as adenomas. The objective of the current multicentric prospective study is to assess the differences in the mucosa adherent intestinal microbiome between patients with MC, non-MC chronic diarrhoea, healthy controls and patients with advanced colon adenomas. In addition to the study of the microbiome, sociodemographic variables, history of drug usage, diets and specific characteristics of diarrhoea will be collected. The hypothesis of the present study is that CM presents a specific mucosa adherent intestinal bacterial profile that may be relevant in the pathogenesis of the disease and that, additionally, may also play a protective role against the development of CRC and adenomas.

NCT ID: NCT06031064 Recruiting - Microscopic Colitis Clinical Trials

External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea

Start date: May 15, 2022
Phase:
Study type: Observational

Chronic watery diarrhoea is a very common problem in the population and most of these patients will be referred for colonoscopy. If no macroscopic findings are observed during colonoscopy to justify the diarrhoea, serial colonic biopsies will be taken to rule out Microscopic Colitis (MC). However, it has been estimated that only 10-15% of these patients will be diagnosed with MC after colonoscopy. Therefore, about 80% of the biopsies collected and analysed will not be useful to establish a diagnosis, considerably increasing costs. To predict the risk of developing MC, a new promising clinical scoring system has been recently developed. This score will be useful in the diagnostic work-up of chronic watery diarrhoea to prioritize colonoscopy with stepwise colonic biopsies in patients with a positive highly specific score for MC. In cases with a negative score, colonoscopy plus biopsies should be performed only if other diagnostic tests are negative. The aim of this current study is to externally validate the new scoring system to predict MC in patients with chronic watery diarrhoea.

NCT ID: NCT05998174 Not yet recruiting - Microscopic Colitis Clinical Trials

Faecal Microbiota Transplantation for Microscopic Colitis

Start date: September 2023
Phase: Early Phase 1
Study type: Interventional

A pilot study investigating if orally administrated faecal microbiota transplantation capsules have the potential to treat active microscopic colitis.

NCT ID: NCT05915104 Not yet recruiting - Microscopic Colitis Clinical Trials

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX [Cortiment] and budesonide CR [Entocort]) work for treating patients with microscopic colitis.

NCT ID: NCT05579444 Terminated - Obesity Clinical Trials

Systems Biology of Gastrointestinal and Related Diseases

Start date: November 11, 2022
Phase:
Study type: Observational

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

NCT ID: NCT05058131 Recruiting - Microscopic Colitis Clinical Trials

Modulation of Intestinal Barrier Function and Inflammation Via Butyrate-promoting Dietary Fibre

Start date: November 3, 2021
Phase: N/A
Study type: Interventional

This study examines how a fermentable dietary fibre known to promote butyrate production impacts intestinal barrier function, intestinal microbiota, intestinal inflammation, and gastrointestinal symptoms in patients with microscopic colitis.

NCT ID: NCT04043897 Recruiting - Microscopic Colitis Clinical Trials

Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis

Start date: June 29, 2018
Phase: Phase 2
Study type: Interventional

This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.

NCT ID: NCT03477032 Recruiting - Ulcerative Colitis Clinical Trials

FMT in Inflammatory Bowel Disease

Start date: June 1, 2018
Phase:
Study type: Observational

This is a prospective observational cohort study, over 52 weeks, evaluating the the use of faecal microbiota transplantation amongst patients with Inflammatory Bowel Disease and Microscopic Colitis

NCT ID: NCT03275467 Completed - Microscopic Colitis Clinical Trials

Faecal Microbiota Transplantation in Patients With Microscopic Colitis

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea, abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized that MC is caused by a deregulated immune response to a luminal agent in predisposed individuals, and an important role of the intestinal microbiota is suggested. In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10 MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy donor into the intestine of a patient with the aim to restore a disturbed intestinal microbiota.

NCT ID: NCT03063957 Recruiting - Clinical trials for Colitis, Microscopic

Identification/Characterization of Changes in Microscopic Colitis

Start date: June 30, 2015
Phase:
Study type: Observational

The goal of this study is to establish a prospective observational cohort of adult patients with microscopic colitis and collect clinical information and specimens over the course of their treatment. This information will be used in order to establish a patient registry with detailed clinical data and a specimen repository for future research as well as to specifically identify genetic and molecular characteristics associated with microscopic colitis.