Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03841045
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
ARIK SEGAL MD, 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.

Condition or disease
Colitis, Ulcerative Crohn Disease

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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
every enrolled people is asked to give saliva, skin and stool samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • UC
  • CD
  • healthy Volunteers

Exclusion Criteria:

• N/A


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: ARIK SEGAL, MD 972-50-7413471 ARIKSE@clalit.org.il
Contact: keren moyal, Ph.D 972-52-7129531 kerenmo@clalit.org.il

Locations
Layout table for location information
Israel
soroka MC Recruiting
Be'er Sheva, Israel
Contact: keren moyal, phd    972-52-7129531    kerenmo@clalit.org.il   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: ARIK SEGAL, MD SOROKA MC

Layout table for additonal information
Responsible Party: ARIK SEGAL MD, principal investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT03841045     History of Changes
Other Study ID Numbers: 0148-15 SOR
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs