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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Hebrew University of Jerusalem
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: August 12, 2008
Last updated: August 13, 2008
Last verified: August 2008

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.

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 ]

Secondary Outcome Measures:
  • A statistically significant relation between micro RNA expression and disease activity and inflammatory indices [ Time Frame: one year ]

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)
Inflammatory bowel disease patients
Average risk patients undergoing screening colonoscopy


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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 identifier: NCT00734331

Contact: Nitsan Maharshak, MD +972-3-6974282

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 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

Keywords provided by Tel-Aviv Sourasky Medical Center:
inflammatory bowel disease
micro RNA
cholinergic tone

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 20, 2017