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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 is a clinical trial that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 54 participants.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-04 |
| Est. Completion | 2017-02-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02872961
The ClinicalTrials.gov registry entry for NCT02872961 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02872961 reports 0 study locations.
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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