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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease; Colitis, Ulcerative

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: ARIK SEGAL, MD; Phone Number: 972-50-7413471; Email: ARIKSE@clalit.org.il
• Study Contact Backup: Name: keren moyal, Ph.D; Phone Number: 972-52-7129531; Email: kerenmo@clalit.org.il

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Recruiting
    • Soroka MC
    • Contact: keren moyal, phd; Phone Number: 972-52-7129531; Email: kerenmo@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

people that have UC, CD diagnosis and healthy can participate in the study. the disease can be at any level and the patients can handle any medications.

each participant will give fresh stool, saliva and skin samples during the study. only one visit is planned in the study-for sighning ICF and returning samples.

Description

Inclusion Criteria:

• UC
• CD
• healthy Volunteers

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ulcerative colitis patient; people that have UC diagnosis can participate in the study. the disease can be at any level and the patients can handle any medications.
CD patient; people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications.
Health people; control group. no IBD patients can be included. patients with other diseases can be included.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: ARIK SEGAL, MD, Soroka MC

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative
• Other Study ID Numbers: 0148-15 SOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No