Confocal Laser Endomicroscopy in IBS Patients

NCT02313207 | Withdrawn

• 1 other identifier: CLE-IBS-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS; Food Intolerance

Outcome Measures

Primary Outcomes (1)

• Detection of mucosal reaction on allergen exposure

  up to 5 sec

Study Arms (2)

FODMAP diet

ACTIVE COMPARATOR

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

Dietary Supplement: FODMAP

Specific bread diet

ACTIVE COMPARATOR

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

Dietary Supplement: FODMAP

Interventions

FODMAP DIETARY_SUPPLEMENT

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

FODMAP diet; Specific bread diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Food Intolerance

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Annette Fritscher-Ravens, MD, PhD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

• Mark Ellrichmann, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Unit of Experimental Endoscopy

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

DE (1)