Intestinal Permeability in Children/Adolescents With Functional Dyspepsia
Completed
Conditions studied: Functional Dyspepsia
In brief
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 also explore the relationships between intestinal permeability, mucosal inflammation and anxiety in FD patients.
Key facts
- Study ID
- NCT00363597
- Run by
- Children's Mercy Hospital Kansas City
- People needed
- 42
- Starts
- 2006-08-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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