Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)

Sponsor
KU Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01912313
Collaborator
(none)
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Study Details

Study Description

Brief Summary

Rectal biopsies from IBS patients or healthy subjects will be taken.

Biopsies will be used for:
  1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and real time PCR (Polymerase chain reaction);

  2. culturing biopsies

On the basis of these observations, the general aim of the study is to move a significant step forward in the current knowledge on human ENS (enteric nervous system) in IBS by establishing a live imaging method to record enteric nerves activity in small intestinal biopsies from humans. This development is unique in its kind as not other research groups have reported successful live recordings with calcium imaging in this preparation.

In particular, the investigators aim:
  1. to develop and validate the technique to measure activity in human enteric nerves in the submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;

  2. to characterize this nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia;

  3. to investigate whether the biopsies of IBS patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons.

  4. to evaluate the influence of different food constituents (cow"s milk, wheat, yeast, gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell activation/degranulation in biopsies of IBS patients compared to healthy subjects.

  5. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
99999999 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)
Study Start Date :
Aug 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rectal biopsy

Procedure: Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy

Outcome Measures

Primary Outcome Measures

  1. nerve activity in healthy subjects and IBS patients [Starting from the moment biopsies are collected untill nerve activity in samples is lost (approximately 5 hours)]

    Measuring nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • IBS patients (based on ROME III Criteria)

  • Healthy subjects

Exclusion Criteria:
  • All subjects with not IBS related complaints

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • KU Leuven

Investigators

  • Principal Investigator: Guy Boeckxstaens, MD, Catholic University Leuven and Universitary Hospitals Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy Boeckxstaens, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier:
NCT01912313
Other Study ID Numbers:
  • S55484
First Posted:
Jul 31, 2013
Last Update Posted:
Feb 9, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Guy Boeckxstaens, Prof. Dr., KU Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2017