---
title: Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing
nct_id: NCT01324895
overall_status: COMPLETED
sponsor: University of Florida
study_type: OBSERVATIONAL
primary_condition: Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01324895.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01324895"
ct_last_update_post_date: 2012-03-26
last_seen_at: "2026-05-12T07:13:06.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing

**NCT ID:** [NCT01324895](https://clinicaltrials.gov/study/NCT01324895)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 944
- **Lead Sponsor:** University of Florida
- **Conditions:** Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Bowel Bacterial Overgrowth Syndrome (SBBOS)
- **Start Date:** 2010-08
- **Completion Date:** 2012-03
- **CT.gov Last Update:** 2012-03-26

## Brief Summary

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.

## Detailed Description

We want to determine whether treatment with prokinetics such as Octreotide, Azithromycin, Erythromycin or Tegaserod alone, versus antibiotics alone, or combination of antibiotics plus prokinetics results in symptomatic improvement in patients with SIBO (defined by a positive D xylose Breath test).

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Primary Outcomes

- **clinical response to treatments as measured by changes in patients' GI symptoms, weight and lab data** _(time frame: 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)_ — 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.

## Locations (1)

- University of Florida, Gainesville, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of florida|gainesville|florida|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01324895*  
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