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
Sponsor:
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
  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

Resource links provided by NLM:


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
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
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 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

No publications provided

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:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014