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NCT00734331 Clinical Trial

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

Inflammatory Bowel Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00734331
Other study ID # TASMC-08-NM-300-CTIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2008
Est. completion date September 2009

Study information
Verified date June 2020
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (2)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 A statistically significant relation between micro RNA expression and disease activity and inflammatory indices one year
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