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

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ClinicalTrials.gov Identifier: NCT01324895
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : March 26, 2012
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease
Small Intestinal Bacterial Overgrowth Syndrome (SIBO) Small Bowel Bacterial Overgrowth Syndrome (SBBOS)

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).

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Study Type : Observational
Actual Enrollment : 944 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Treatment Outcomes in Patients With Bacterial Overgrowth Syndrome Diagnosed by D-Xylose Breath Testing
Study Start Date : August 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had 14 C-D-Xylose Breath test performed in GI Motility Laboratory at the University of Florida to help define the cause of their symptoms and for diagnosis of SIBO, between January 2000 up until the date of IRB approval.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324895


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Baharak Moshiree, MD, MS University of Florida

Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01324895     History of Changes
Other Study ID Numbers: 406-2010
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by University of Florida:
Small intestinal bacterial overgrowth syndrome (SIBO)
bacterial overgrowth syndrome
Small Bowel Bacterial Overgrowth Syndrome (SBBOS)
14-Co2 D-Xylose Breath Testing
Antibiotics
Prokinteics
Prokinetic Agents
Additional relevant MeSH terms:
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Blind Loop Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases