Intestinal Response Patterns to Microbial Signals

NCT03872622 | Completed

• 1 other identifier: 5484-18-SMC
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

CD - Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Correlation of microbiomic profile with dietary-environmental exposures in rural healthy population compared with urban healthy population in China and with new-onset Crohn's disease in Israel and China

  Measurements: questionaries, physiological parameters (blood, stool, biopsies), inflammatory markers

  A pilot study of 18 months

Study Arms (2)

CD patients

OTHER

New onset Crohn's disease patients

Other: Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire

Healthy controls

OTHER

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

Interventions

Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire OTHER

Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire.

CD patients; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Weizmann Institute of Science: collaborator
• Washington University School of Medicine: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 580301992, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Shomron Ben Horin

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: March 13, 2019
• Study Start: November 27, 2018
• Primary Completion: June 1, 2021
• Study Completion: August 29, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

IL (1)