Confocal Laser Endomicroscopy in IBS Patients

Not Applicable

Withdrawn

• Conditions: IBS; Food Intolerance
• Interventions: Dietary Supplement: FODMAP

• Registration Number: NCT02313207
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-09
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

IBS according to the Rome III criteria moderate/severe refractory daily symptoms >1year (FGID-C1) sub classified as IBS-D, constipation predominant (IBS-C) or mixed type (IBS-M) no past infection to trigger symptom no structural/ biochemical cause of their symptoms identified negative gastroscopy, colonoscopy including histology Worsening symptoms after meals various exclusion diets - ineffective females not menstruating during CLE no known allergy to methylene blue or fluorescein Age >18 years Negative routine testing for food intolerance (or known lactose/fructose intolerance) Positive informed consent

Exclusion Criteria

no consent known reason for the abdominal pain and bloating other than lactose/fructose intolerance M. Whipple Known infectious gastrointestinal disease Stricture in the upper gastrointestinal tract Age <18years Impaired renal function (Creatinine >1.2 mg/dL) Pregnancy or breast-feeding Inability to obtain informed consent Active GI Bleeding Known allergy to Methylene blue or Fluorescein Participation in other clinical trials within the last 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Specific bread diet	FODMAP	Specific bread diet eliminating wheat and yeast for 2 weeks, patients will undergo a specific FODMAP diet for a period of 2 weeks.
FODMAP diet	FODMAP	FODMAP diet for 2 weeks, patients will undergo a specific FODMAP diet for a period of 2 weeks.

Primary Outcome Measures

Name	Time	Method
Detection of mucosal reaction on allergen exposure	up to 5 sec

Trial Locations

Locations (1)

University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy; 🇩🇪 Kiel, Germany