- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02313207
Confocal Laser Endomicroscopy in IBS Patients
Confocal Endomicroscopy for the Detection of Food Intolerances in Patients With IBS.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kiel, Germany, 24105
- University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: FODMAP diet
FODMAP diet for 2 weeks, patients will undergo a specific FODMAP diet for a period of 2 weeks.
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patients will undergo a specific FODMAP diet for a period of 2 weeks.
|
ACTIVE_COMPARATOR: Specific bread diet
Specific bread diet eliminating wheat and yeast for 2 weeks, patients will undergo a specific FODMAP diet for a period of 2 weeks.
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patients will undergo a specific FODMAP diet for a period of 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Detection of mucosal reaction on allergen exposure
Time Frame: up to 5 sec
|
up to 5 sec
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLE-IBS-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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