- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00734331
Micro Ribonucleic Acid (RNA) as Cholinergic Tone and Inflammatory Regulator in Inflammatory Bowel Disease
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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IBD
Inflammatory bowel disease patients
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Control
Average risk patients undergoing screening colonoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Elevated expression of specific micro RNAs that regulate the expression of the enzyme Acetylcholine esterase in inflammatory bowel disease patients compared to healthy controls.
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A statistically significant relation between micro RNA expression and disease activity and inflammatory indices
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-08-NM-300-CTIL
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