NCT02313207

Confocal Laser Endomicroscopy in IBS Patients

Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	FODMAP	patients will undergo a specific FODMAP diet for a period of 2 weeks.

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2014-12-09
• Last updated: 2022-07-06

Locations

1 site across 1 country: Germany