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Intestinal Response Patterns to Microbial Signals

NCT03872622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-04-05

No results posted yet for this study

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).

Conditions

  • CD - Crohn's Disease

Interventions

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.

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2021-06-01
Completion
2023-08-29

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872622 on ClinicalTrials.gov