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Intestinal Response Patterns to Microbial Signals

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ClinicalTrials.gov Identifier: NCT03872622
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Weizmann Institute of Science
Washington University School of Medicine
Sun Yat-sen University
Information provided by (Responsible Party):
Prof. Shomron BenHorin, Sheba Medical Center

Brief Summary:

A cohort of CD patients (total n=300) and a cohort of controls (healthy individuals and family members of CD patients, total n=200) will be recruited.

We will analyze gut host pattern of tissue immune system and epithelial responses to putative exposome and microbial triggers, expression data in the gut using mRNA expression studies and genetic analysis of the resident bacterial flora are necessary to identify specific molecules and signal pathways as well as specific bacterial taxa involved in aberrant response and instigation of inflammation that is the driver of Crohn's disease. Therefore, We will obtain stool & blood samples and intestinal biopsy and/or resection specimens from CD patients, and blood, stool and intestinal biopsy samples from healthy individuals and a-symptomatic family relatives undergoing colonoscopy for reasons un-related to the study (e.g screening colonoscopy).

Patients from both cohorts will also undergo environmental and dietary exposure survey. For environmental exposure, we will use the questionnaire developed by the International Organization of IBD (IOIBD), with some modification. Questions relate to five main different areas: (i) Childhood factors up to 20 years; (ii) food habits including daily, weekly or less frequent consumption; (iii) smoking habits; (iv) sanitary conditions such as the availability of in-house water tap, hot water tap or flush toilet; and (v) others factors including physical activity, oral contraceptive pill and stressful events before diagnosis.

For mapping dietary habits we will employ an interview conducted by a trained dietician and using the validated structured FFQ (Food frequency Questionnaire).


Condition or disease Intervention/treatment Phase
CD - Crohn's Disease Other: Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intestinal Response Patterns to Microbial Signals in the Healthy Rural & Urban and in the Crohn's Disease Host Gut
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
CD patients
New onset Crohn's disease patients
Other: Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire
Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire.

Healthy controls
Patients' family members and healthy subjects undergoing colonoscopy for non-research purposes
Other: Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire
Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire.




Primary Outcome Measures :
  1. Correlation of microbiomic profile with dietary-environmental exposures in rural healthy poulation compared with urban healty population in China and with new-onset Crohn's disease in Israel and China [ Time Frame: A pilot study of 18 months ]
    Correlation of microbiomic profile with dietary-environmental exposures in rural healthy poulation compared with urban healty population in China and with new-onset Crohn's disease in Israel and China



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults>18YO
  • CD patients: known CD\ new-onset CD\ travelling CD or controls: healthy individuals\ family members of CD patients

Exclusion Criteria:

  • Age<18YO
  • pregnant women
  • inability to provide informed consent
  • drug/alcohol abuse

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): NCT03872622


Contacts
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Contact: Shomron Ben Horin, Prof. 03-5302660 shomron.benhorin@gmail.com
Contact: Yael Haberman, Dr. 03-5302033 Yael.Haberman@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 580301992
Contact: Shomron Ben Horin, Prof       shomron.benhorin@gmail.com   
Contact: Yael Haberam, Dr       Yael.Haberman@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Weizmann Institute of Science
Washington University School of Medicine
Sun Yat-sen University

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Responsible Party: Prof. Shomron BenHorin, Prof. Shomron Ben Horin, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03872622     History of Changes
Other Study ID Numbers: 5484-18-SMC
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases