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NCT02872961 · ClinicalTrials.gov registry record
SIBO, Immune Activation, and FGIDs in Children
A clinical trial, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- 54
- Enrollment target
NCT02872961: Completed study, sponsored by The University of Texas Health Science Center, Houston.
NCT02872961 is a clinical trial that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02872961 has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- 54 participants
- Enrollment target
Study Summary
PURPOSE: This study will evaluate the relationships between small intestinal bacterial overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome (IBS), functional dyspepsia (FD), \& functional abdominal pain (FAP), to better understand the role of SIBO in their pathogenesis. DESIGN \& PROCEDURES: Cross-sectional study. Subjects: Patients followed at the UT-Houston Pediatric GI clinic, aged 4-17 years, undergoing endoscopic evaluation of abdominal pain, meeting Rome III diagnostic criteria for IBS, FD, or FAP, without evidence of an organic etiology of abdominal pain upon routine laboratory, radiologic, endoscopic, histologic evaluation. Sample Size: At least 30 patients, ≥ 15 with SIBO (i.e., positive small bowel aspirate culture and/or glucose breath hydrogen test), and ≥15 without SIBO. Sample Materials: Small bowel biopsies and aspirates, serum, breath samples, symptom questionnaire responses. Measures: 1) Immune activation \& inflammation - measured by serum cytokine levels \& small intestinal tissue inflammatory cell infiltration \& cytokine levels. 2) Symptoms - measured by Abdominal Pain Index, Wong-Baker FACES™ Pain Rating Scale, Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III Version. 3) Small bowel microbiota analysis - assessed by 454 pyrosequencing. RISKS \& POTENTIAL BENEFITS: Aside from the risks associated with routine endoscopy with biopsies, which would occur even without study enrollment, the risks associated with serum collection, one extra biopsy specimen collection, small bowel aspirate collection, completion of pain scales/ questionnaires, and the glucose breath hydrogen test for the purposes of the study are minimal. POTENTIAL IMPACT: This study should yield valuable information regarding the relationships between SIBO, immune activation, inflammation, and symptoms in pediatric IBS, FD, and FAP. Potential bio
Primary Outcome
To further evaluate symptom severity, on the day of endoscopic evaluation, each subject (or the legal guardian, when appropriate) will be asked to complete the Abdominal Pain Index, which is comprised of five items assessing the frequency, duration, and intensity of abdominal pain episodes the subject has experienced during the previous two weeks. This index was previously validated as a clinical measure of abdominal pain in pediatric patients. Responses to the five pain ratings are standardized
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-04 |
| Est. Completion | 2017-02-13 |
What the finished NCT02872961 record still lists
NCT02872961 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02872961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02872961 about?
NCT02872961 is a clinical study titled "SIBO, Immune Activation, and FGIDs in Children". PURPOSE: This study will evaluate the relationships between small intestinal bacterial overgrowth (SIBO), immune activation, inflammation, and symptoms in pediatric abdominal pain-related functional gastrointestinal disorders (FGIDs), i.e., irritable bowel syndrome (IBS), functional dyspepsia (FD), ...
What is the current status of trial NCT02872961?
This trial is currently completed. The enrollment target is 54 participants. The study started on 2013-04. Estimated completion is 2017-02-13.
Who is sponsoring clinical trial NCT02872961?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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