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Confocal Laser Endomicroscopy in IBS Patients

Primary Purpose

IBS, Food Intolerance

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FODMAP
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
December 5, 2014
Last Updated
June 30, 2022
Sponsor
University Hospital Schleswig-Holstein
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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
No

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
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

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Confocal Laser Endomicroscopy in IBS Patients

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