Expired Study
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Gainesville, Florida


Purpose:

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.


Study summary:

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).


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


Study is Available At:


Original ID:

406-2010


NCT ID:

NCT01324895


Secondary ID:


Study Acronym:

SIBO


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Florida


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

944


Enrollment Type:

Actual


Overall Contact Information

Official Name:Baharak Moshiree, MD, MS
Principal Investigator
University of Florida

Study Dates

Start Date:August 2010
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 19, 2012
First Received Date:March 24, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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 retrospect

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Florida

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:18802998
Reference Type:Reference
Citation: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.
PMID:1944424
Reference Type:Reference
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.
PMID:7555439
Reference Type:Reference
Citation:Attar A, Flourié 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.
PMID:10500060
Reference Type:Reference
Citation:Pimentel M. Review of rifaximin as treatment for SIBO and IBS. Expert Opin Investig Drugs. 2009 Mar;18(3):349-58. Review.
PMID:19243285
Reference Type:Reference
Citation: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.
PMID:447030
Reference Type:Reference
Citation: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. Epub 2010 Jan 6.
PMID:20060064
Reference Type:Reference
Citation:Singh VV, Toskes PP. Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment. Curr Treat Options Gastroenterol. 2004 Feb;7(1):19-28.
PMID:14723835

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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