Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2016
CompletedFirst Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 15, 2019
February 1, 2019
4.2 years
September 5, 2018
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- healthy Volunteers
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
soroka MC
Beersheba, Israel
Biospecimen
every enrolled people is asked to give saliva, skin and stool samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ARIK SEGAL, MD
SOROKA MC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 5, 2018
First Posted
February 15, 2019
Study Start
September 14, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share