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

NCT ID: NCT03841045

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-14

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Colitis, Ulcerative Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Health people

control group. no IBD patients can be included. patients with other diseases can be included.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* UC
* CD
* healthy Volunteers

Exclusion Criteria

• N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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ARIK SEGAL MD

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ARIK SEGAL, MD

Role: PRINCIPAL_INVESTIGATOR

SOROKA MC

Locations

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soroka MC

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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ARIK SEGAL, MD

Role: CONTACT

972-50-7413471

keren moyal, Ph.D

Role: CONTACT

972-52-7129531

Facility Contacts

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keren moyal, phd

Role: primary

972-52-7129531

Other Identifiers

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0148-15 SOR

Identifier Type: -

Identifier Source: org_study_id

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