Micro Ribonucleic Acid (RNA) as Cholinergic Tone and Inflammatory Regulator in Inflammatory Bowel Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00734331
First received: August 12, 2008
Last updated: August 13, 2008
Last verified: August 2008
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Purpose
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 |
|---|
|
Inflammatory Bowel Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Further study details as provided by Tel-Aviv Sourasky Medical Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- A statistically significant relation between micro RNA expression and disease activity and inflammatory indices [ Time Frame: one year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum, colonic tissue, whole blood
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
IBD
Inflammatory bowel disease patients
|
|
Control
Average risk patients undergoing screening colonoscopy
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients- inflammatory bowel disease patients under going colonoscopy controls- average risk patients without inflammation under going colonoscopy
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734331
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734331
Contacts
| Contact: Nitsan Maharshak, MD | +972-3-6974282 | nitzanm@tasmc.health.gov.il |
Locations
| Israel | |
| Tel Aviv Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel | |
| Principal Investigator: Nitsan Maharshak, MD | |
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Hebrew University of Jerusalem
More Information
| Responsible Party: | Nitsan Maharshak, Physician Gastroenterology and Liver Diseases Dept., Tel Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT00734331 History of Changes |
| Other Study ID Numbers: | TASMC-08-NM-300-CTIL |
| Study First Received: | August 12, 2008 |
| Last Updated: | August 13, 2008 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
inflammatory bowel disease micro RNA cholinergic tone inflammation |
Additional relevant MeSH terms:
|
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016