Back to results

Confocal Laser Endomicroscopy in IBS Patients

Primary Purpose

IBS, Food Intolerance

Status

Withdrawn

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

FODMAP

About this trial

This is an interventional treatment trial for IBS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

FODMAP diet

Specific bread diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Detection of mucosal reaction on allergen exposure

Secondary Outcome Measures

Full Information

NCT ID

NCT02313207

First Posted

December 5, 2014

Last Updated

June 30, 2022

Sponsor

University Hospital Schleswig-Holstein

1. Study Identification

Unique Protocol Identification Number

NCT02313207

Brief Title

Confocal Laser Endomicroscopy in IBS Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Withdrawn

Why Stopped

No appropriate participants

Study Start Date

November 2014 (Actual)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IBS, Food Intolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FODMAP diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

Specific bread diet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

FODMAP

Intervention Description

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

Primary Outcome Measure Information:

Title

Detection of mucosal reaction on allergen exposure

Time Frame

up to 5 sec

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annette Fritscher-Ravens, MD, PhD

Organizational Affiliation

University Hospital Schleswig-Holstein

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark Ellrichmann, MD

Organizational Affiliation

University Hospital Schleswig-Holstein

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy

City

Kiel

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Confocal Laser Endomicroscopy in IBS Patients

We'll reach out to this number within 24 hrs