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Micro Ribonucleic Acid (RNA) as Cholinergic Tone and Inflammatory Regulator in Inflammatory Bowel Disease

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00734331
Collaborator
Hebrew University of Jerusalem (Other)
40
Enrollment
1
Location
12
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a reciprocal relationship between the central nervous system and the immune system. Stimulation of the vagus nerve results in secretion of acetylcholine (Ach) which decreases secretion of pro-inflammatory cytokines. Acetylcholine esterase is an enzyme that neutralizes Ach and thus, involves in regulation of Ach levels, and in the cholinergic tone and inflammatory state.

MicroRNAs (miRs) are evolutionarily conserved, RNAs that regulate gene expression. The investigators hypothesized that miRs controlling systemic communication processes function in one tissue in response to signals (i.e. neuronal, hormonal or others) from another.

Specifically, the investigators hypothesized that miRs control the inflammatory response in inflammatory bowel diseases through regulation of expression of messenger RNA of AchE.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Sep 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2009
    Actual Study Completion Date :
    Sep 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    IBD

    Inflammatory bowel disease patients
    Control

    Average risk patients undergoing screening colonoscopy

    Outcome Measures

    Primary Outcome Measures

    1. Elevated expression of specific micro RNAs that regulate the expression of the enzyme Acetylcholine esterase in inflammatory bowel disease patients compared to healthy controls. [one year]

    Secondary Outcome Measures

    1. A statistically significant relation between micro RNA expression and disease activity and inflammatory indices [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Inflammatory bowel disease patients under going colonoscopy
    Exclusion Criteria:

    • Debilitated patients who need an apotropsy

    • Age < 18 or age > 75

    • Pregnant women

    • Evidence of previous or current cancer

    • Inflammatory disease other than IBD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tel Aviv Sourasky Medical Center Tel Aviv Israel

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center
    • Hebrew University of Jerusalem

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    michal roll, MicroRNA-132 Modulates Cholinergic Signaling and Inflammation in Human Inflammatory Bowel Disease, Tel-Aviv Sourasky Medical Center
    ClinicalTrials.gov Identifier:
    NCT00734331
    Other Study ID Numbers:
    • TASMC-08-NM-300-CTIL
    First Posted:
    Aug 14, 2008
    Last Update Posted:
    Jun 16, 2020
    Last Verified:
    Jun 1, 2020
    Keywords provided by michal roll, MicroRNA-132 Modulates Cholinergic Signaling and Inflammation in Human Inflammatory Bowel Disease, Tel-Aviv Sourasky Medical Center
    inflammatory bowel disease
    micro RNA
    cholinergic tone
    inflammation
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Jun 16, 2020