Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
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|ClinicalTrials.gov Identifier: NCT03841045|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
|Condition or disease|
|Colitis, Ulcerative Crohn Disease|
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|
|Estimated Enrollment :||150 participants|
|Official Title:||Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases|
|Actual Study Start Date :||September 14, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications.
control group. no IBD patients can be included. patients with other diseases can be included.
- change of bilirubin metabolism in fecal samples [ Time Frame: 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 [ Time Frame: an average of 1 year after recruitment ]16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841045
|Contact: ARIK SEGAL, MD||972-50-7413471||ARIKSE@clalit.org.il|
|Contact: keren moyal, Ph.Dfirstname.lastname@example.org|
|Be'er Sheva, Israel|
|Contact: keren moyal, phd 972-52-7129531 email@example.com|
|Principal Investigator:||ARIK SEGAL, MD||SOROKA MC|