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

NCT01912313 | Recruiting

• 1 other identifier: S55484
• Study Type: interventional
• Target: 99,999,999
• Locations: 1 country
• Sites: 1

Brief Summary

Rectal biopsies from IBS patients or healthy subjects will be taken. Biopsies will be used for:

1. 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. 2.culturing biopsies
3. 3.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;
4. 4.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;
5. 5.to investigate whether the biopsies of IBS patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons.
6. 6.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.
7. 7.To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling

Conditions

IBS; Healthy

Keywords

IBS patients; healthy subjects

Outcome Measures

Primary Outcomes (1)

• nerve activity in healthy subjects and IBS patients

  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.

  Starting from the moment biopsies are collected untill nerve activity in samples is lost (approximately 5 hours)

Study Arms (1)

Rectal biopsy

EXPERIMENTAL

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

Interventions

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

Rectal biopsy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS patients (based on ROME III Criteria)
• Healthy subjects

You may not qualify if:

• \- All subjects with not IBS related complaints

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Officials

• Guy Boeckxstaens, MD

  Catholic University Leuven and Universitary Hospitals Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Bellens, MSc

CONTACT

0032-16-341943; koen.bellens@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

BE (1)