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

Primary Purpose

IBS, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for IBS focused on measuring IBS patients, healthy subjects

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- All subjects with not IBS related complaints

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rectal biopsy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2013
Last Updated
February 7, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01912313
Brief Title
Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)
Official Title
Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rectal biopsies from IBS patients or healthy subjects will be taken. Biopsies will be used for: 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); 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: 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; 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; to investigate whether the biopsies of IBS patients secrete more modulators/cytokines compared to healthy subjects and their potential to activate neurons. 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. To evaluate the amount of inflammatory mediators/metabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS, Healthy
Keywords
IBS patients, healthy subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99999999 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectal biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy
Primary Outcome Measure Information:
Title
nerve activity in healthy subjects and IBS patients
Description
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.
Time Frame
Starting from the moment biopsies are collected untill nerve activity in samples is lost (approximately 5 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: IBS patients (based on ROME III Criteria) Healthy subjects Exclusion Criteria: - All subjects with not IBS related complaints
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Bellens, MSc
Phone
0032-16-341943
Email
koen.bellens@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, MD
Organizational Affiliation
Catholic University Leuven and Universitary Hospitals Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Bellens, MSc
Phone
0032-16-341943
Email
koen.bellens@kuleuven.be

12. IPD Sharing Statement

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

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