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Confocal Laser Endomicroscopy in IBS Patients

NCT02313207 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-06

No results posted yet for this study

Summary

This study will assess dynamic effects of two major antigens on the duodenal mucosa by confocal laser endomicroscopy (CLE). Patients will be blinded to the antigens used (wheat, yeast). Following CLE it is planned to have a cross over exclusion diet with/without the antigens including a washout phase. Furthermore, patients will undergo a 2 week FODMAP diet to be able to compare results found of both diets and allow to understand whether our findings of food intolerance will be better and more precise than a common FODMAP diet.

Post CLE food challenge patients biopsies will be taken for histology. They will then be randomized into two groups and blinded to the diet they undergo. They will be provided with a supply of custom-made bread they will have for 2 weeks (custom made by a bakery in Kiel). For one study arm bread will contain either wheat and yeast, for the other arm the bread will not contain these ingredients. The taste of the "normal" bread will be denaturised. Crossover will take place after a two-week washout phase.

Conditions

  • IBS
  • Food Intolerance

Interventions

DIETARY_SUPPLEMENT

FODMAP

patients will undergo a specific FODMAP diet for a period of 2 weeks.

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Annette Fritscher-Ravens, MD, PhD · University Hospital Schleswig-Holstein

  • Mark Ellrichmann, MD · University Hospital Schleswig-Holstein

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313207 on ClinicalTrials.gov