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

NCT00734331 | Completed

• 1 other identifier: TASMC-08-NM-300-CTIL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

inflammatory bowel disease; micro RNA; cholinergic tone; inflammation

Outcome Measures

Primary Outcomes (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.

  one year

Secondary Outcomes (1)

• A statistically significant relation between micro RNA expression and disease activity and inflammatory indices

  one year

Study Arms (2)

IBD

Inflammatory bowel disease patients

Control

Average risk patients undergoing screening colonoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Inflammatory bowel disease patients under going colonoscopy

You may not qualify if:

• Debilitated patients who need an apotropsy
• Age \< 18 or age \> 75
• Pregnant women
• Evidence of previous or current cancer
• Inflammatory disease other than IBD

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, colonic tissue, whole blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Inflammation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MicroRNA-132 Modulates Cholinergic Signaling and Inflammation in Human Inflammatory Bowel Disease

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

IL (1)