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

NCT ID: NCT01324895

Last Updated: 2012-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

944 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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).

Conditions

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Small Intestinal Bacterial Overgrowth Syndrome (SIBO) Small Bowel Bacterial Overgrowth Syndrome (SBBOS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Baharak Moshiree, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Singh VV, Toskes PP. Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment. Curr Treat Options Gastroenterol. 2004 Feb;7(1):19-28. doi: 10.1007/s11938-004-0022-4.

Reference Type BACKGROUND
PMID: 14723835 (View on PubMed)

Lombardo L, Foti M, Ruggia O, Chiecchio A. Increased incidence of small intestinal bacterial overgrowth during proton pump inhibitor therapy. Clin Gastroenterol Hepatol. 2010 Jun;8(6):504-8. doi: 10.1016/j.cgh.2009.12.022. Epub 2010 Jan 6.

Reference Type BACKGROUND
PMID: 20060064 (View on PubMed)

King CE, Toskes PP, Spivey JC, Lorenz E, Welkos S. Detection of small intestine bacterial overgrowth by means of a 14C-D-xylose breath test. Gastroenterology. 1979 Jul;77(1):75-82. No abstract available.

Reference Type BACKGROUND
PMID: 447030 (View on PubMed)

Pimentel M. Review of rifaximin as treatment for SIBO and IBS. Expert Opin Investig Drugs. 2009 Mar;18(3):349-58. doi: 10.1517/13543780902780175.

Reference Type BACKGROUND
PMID: 19243285 (View on PubMed)

Attar A, Flourie B, Rambaud JC, Franchisseur C, Ruszniewski P, Bouhnik Y. Antibiotic efficacy in small intestinal bacterial overgrowth-related chronic diarrhea: a crossover, randomized trial. Gastroenterology. 1999 Oct;117(4):794-7. doi: 10.1016/s0016-5085(99)70336-7.

Reference Type BACKGROUND
PMID: 10500060 (View on PubMed)

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. doi: 10.1007/BF02208652.

Reference Type BACKGROUND
PMID: 7555439 (View on PubMed)

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. doi: 10.1056/NEJM199111213252102.

Reference Type BACKGROUND
PMID: 1944424 (View on PubMed)

Lauritano EC, Gabrielli M, Scarpellini E, Lupascu A, Novi M, Sottili S, Vitale G, Cesario V, Serricchio M, Cammarota G, Gasbarrini G, Gasbarrini A. Small intestinal bacterial overgrowth recurrence after antibiotic therapy. Am J Gastroenterol. 2008 Aug;103(8):2031-5. doi: 10.1111/j.1572-0241.2008.02030.x.

Reference Type BACKGROUND
PMID: 18802998 (View on PubMed)

Other Identifiers

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406-2010

Identifier Type: -

Identifier Source: org_study_id

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