Small Bowel Bacterial Overgrowth Syndrome (SBBOS) Clinical Trial
— SIBOOfficial title:
Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing
| Verified date | March 2012 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
The objective of this study is to compare the efficacy of prokinetics versus antibiotics
versus a combination of antibiotics plus prokinetics in the eradication of Small-Intestinal
Bacterial Over-Growth Syndrome (SIBO) in those with and without a positive D-xylose Breath
Test.
Hypothesis: Patients with SIBO treated with a combination of prokinetics and in particular
octreotide and antibiotics will have reduced recurrence rates of SIBO than either therapy
given alone.
| Status | Completed |
| Enrollment | 944 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients who have had 14 C-D-Xylose Breath test performed in GI Motility Laboratory at the University of Florida Exclusion Criteria: - Those who cannot tolerate 14 C-D-Xylose Breath test for any reason |
Observational Model: Case Control, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Florida | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida |
United States,
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Soudah HC, Hasler WL, Owyang C. Effect of octreotide on intestinal motility and bacterial overgrowth in scleroderma. N Engl J Med. 1991 Nov 21;325(21):1461-7. — View Citation
Verne GN, Eaker EY, Hardy E, Sninsky CA. Effect of octreotide and erythromycin on idiopathic and scleroderma-associated intestinal pseudoobstruction. Dig Dis Sci. 1995 Sep;40(9):1892-901. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical response to treatments as measured by changes in patients' GI symptoms, weight and lab data | Overall clinical response to each treatment (antibiotic, pro-kinetic, or both) and any symptoms reported in up to 8 separate clinical visits in the follow-up of these patients during the above mentioned time period will be analyzed and reviewed retrospectively using the patients' charts. | A retrospective chart review of up to 8 clinical visits between January 2000 and September 2010 will be conducted on all patients who have had a D-Xylose Breath Test at the Shands Motility Laboratory at the University of Florida during this time period | No |