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

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ClinicalTrials.gov Identifier: NCT00734331
Recruitment Status : Unknown
Verified August 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2008
Last Update Posted : August 14, 2008
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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Brief 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.


Condition or disease
Inflammatory Bowel Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : September 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009
Groups and Cohorts
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Group/Cohort
IBD
Inflammatory bowel disease patients
Control
Average risk patients undergoing screening colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria
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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
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

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