This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Guy Boeckxstaens, Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01912313
First received: July 29, 2013
Last updated: February 7, 2017
Last verified: February 2017
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)

Resource links provided by NLM:


Further study details as provided by Guy Boeckxstaens, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • nerve activity in healthy subjects and IBS patients [ Time Frame: 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.


Estimated Enrollment: 99999999
Study Start Date: August 2013
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rectal biopsy Procedure: Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- All subjects with not IBS related complaints

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912313

Contacts
Contact: Lien Beullens, MSc 0032-16-341943 lien.beullens@kuleuven.be
Contact: Dafne Balemans, MSc 0032-16-330158 dafne.balemans@med.kuleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Lien Beullens, MSc    0032-16-341943    lien.beullens@kuleuven.be   
Contact: Dafne Balemans, MSc    0032-16-330158    dafne.balemans@med.kuleuven.be   
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Guy Boeckxstaens, MD Catholic University Leuven and Universitary Hospitals Leuven
  More Information

Responsible Party: Guy Boeckxstaens, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01912313     History of Changes
Other Study ID Numbers: S55484
Study First Received: July 29, 2013
Last Updated: February 7, 2017

Keywords provided by Guy Boeckxstaens, Katholieke Universiteit Leuven:
IBS patients
healthy subjects

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 19, 2017