Status:
COMPLETED
Intestinal Permeability in Children/Adolescents With Functional Dyspepsia
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
8-17 years
Brief Summary
The main purpose of this study is to evaluate whether intestinal permeability and/or serum zonulin concentration is increased in children/adolescents with functional dyspepsia (FD). The study will als...
Detailed Description
Recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. It represents the most common chronic pain entity in pediatric patients. The gre...
Eligibility Criteria
Inclusion
- abdominal pain of at least 8 weeks duration and fulfilling Rome II symptom based criteria for functional dyspepsia (patient group only);
- undergoing endoscopy to evaluate FD following demonstration of a lack of clinical response to standard acid reduction therapy (patient group only); and,
- informed permission/assent
Exclusion
- previous abdominal surgery;
- any chronic non-gastrointestinal illness requiring regular medical care (e.g. diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer);
- any history of an adverse reaction to lactulose or mannitol;
- any use of antacids or laxatives within 1 week prior to the study;
- any use of steroids, antihistamines or antihistamine-like drugs within 4 weeks prior to the study;
- any use of aspirin is prohibited within one week prior to the study;
- any use of non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin is restricted within one week prior to the study or at the discretion of the Study Physician;
- any use of antibiotics including neomycin (Mycifradin) within 4 weeks prior to the study;
- pregnancy;
- any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation (healthy control group only); or
- non-English speaking
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00363597
Start Date
August 1 2006
End Date
July 1 2010
Last Update
December 19 2020
Active Locations (1)
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1
The Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108