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CompletedNCT00734331Updated Jun 16, 2020

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

An observational study in Inflammatory Bowel Disease, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Inflammatory Bowel Disease

Keywords

  • inflammatory bowel disease
  • micro RNA
  • cholinergic tone
  • inflammation
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In context

Intestinal Diseases

964 studies on the registry are indexed under Intestinal Diseases; 176 are open to participants now.

This study's enrollment of 40 is below the median of 139 across 378 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • IBD

    Inflammatory bowel disease patients

  • Control

    Average risk patients undergoing screening colonoscopy

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What researchers measure

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.

    Time frame: one year

Secondary outcomes

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

    Time frame: one year

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Study locations

1 site
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00734331
Lead sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Hebrew University of Jerusalem
Responsible party
michal roll (MicroRNA-132 Modulates Cholinergic Signaling and Inflammation in Human Inflammatory Bowel Disease, Tel-Aviv Sourasky Medical Center) — Principal investigator
First posted
Aug 14, 2008
Start date
Sep 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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