Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

• Conditions: Crohn Disease; Colitis, Ulcerative

• Registration Number: NCT03841045
• Lead Sponsor: Soroka University Medical Center

Brief Summary

Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.

Detailed Description

Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable.

The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.

Study Timeline

• Study Start: 2016-09-14
• Study First Submitted: 2018-09-05
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• UC
• CD
• healthy Volunteers

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of bilirubin metabolism in fecal samples	an average of 1 year after recruitment	liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts
microbial diversity of fecal matter	an average of 1 year after recruitment	16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients

Trial Locations

Locations (1)

soroka MC; 🇮🇱 Be'er Sheva, Israel