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OpenTrials
Completed

NCT Number: NCT01324895

Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: SIBO

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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