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

NCT01324895 | Completed

• 1 other identifier: 406-2010
• Study Type: observational
• Target: 944
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• clinical response to treatments as measured by changes in patients' GI symptoms, weight and lab data

  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.

  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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who have had 14 C-D-Xylose Breath test performed in GI Motility Laboratory at the University of Florida

You may not qualify if:

• Those who cannot tolerate 14 C-D-Xylose Breath test for any reason

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (8)

• 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.

  PMID: 14723835 BACKGROUND

• 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.

  PMID: 20060064 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19243285 BACKGROUND

• 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.

  PMID: 10500060 BACKGROUND

• 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.

  PMID: 7555439 BACKGROUND

• 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.

  PMID: 1944424 BACKGROUND

• 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.

  PMID: 18802998 BACKGROUND

MeSH Terms

Conditions

Blind Loop Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Baharak Moshiree, MD, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

US (1)