Status:
WITHDRAWN
Confocal Laser Endomicroscopy in IBS Patients
Lead Sponsor:
University Hospital Schleswig-Holstein
Conditions:
IBS
Food Intolerance
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02313207
Start Date
November 1 2014
End Date
December 1 2018
Last Update
July 6 2022
Active Locations (1)
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1
University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy
Kiel, Germany, 24105