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

August 12, 2008
August 13, 2008
September 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00734331 on ClinicalTrials.gov Archive Site
A statistically significant relation between micro RNA expression and disease activity and inflammatory indices [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Micro Ribonucleic Acid (RNA) as Cholinergic Tone and Inflammatory Regulator in Inflammatory Bowel Disease
Not Provided

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, colonic tissue, whole blood

Non-Probability Sample

Patients- inflammatory bowel disease patients under going colonoscopy controls- average risk patients without inflammation under going colonoscopy

Inflammatory Bowel Disease
Not Provided
  • IBD
    Inflammatory bowel disease patients
  • Control
    Average risk patients undergoing screening colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Nitsan Maharshak, MD +972-3-6974282 nitzanm@tasmc.health.gov.il
Israel
 
NCT00734331
TASMC-08-NM-300-CTIL
No
Nitsan Maharshak, Physician Gastroenterology and Liver Diseases Dept., Tel Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Hebrew University of Jerusalem
Not Provided
Tel-Aviv Sourasky Medical Center
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP