ClinicalTrials.gg
CompletedNCT01324895SIBOUpdated Mar 26, 2012

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

An observational study in Small Intestinal Bacterial Overgrowth Syndrome (SIBO) and Small Bowel Bacterial Overgrowth Syndrome (SBBOS), sponsored by University of Florida. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-03-26.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
944
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

Browse trials for

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
03

In context

Blind Loop Syndrome

11 studies on the registry are indexed under Blind Loop Syndrome; 4 are open to participants now.

Browse Blind Loop Syndrome studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those who cannot tolerate 14 C-D-Xylose Breath test for any reason
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
944 participants (actual)
06

What researchers measure

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.

    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

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32610, United States
08

References and documents

Publications

  • 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. PubMed 14723835 ↗
  • 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. PubMed 20060064 ↗
  • 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. PubMed 447030 ↗
  • 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. PubMed 19243285 ↗
  • 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. PubMed 10500060 ↗
  • 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. PubMed 7555439 ↗
  • 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. PubMed 1944424 ↗
  • 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. PubMed 18802998 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2010, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2011
First posted
Mar 29, 2011
Start
Aug 2010
Primary completionActual
Mar 2012
CompletionActual
Mar 2012
Last update
Mar 26, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01324895
Responsible party
Sponsor
First posted
Mar 29, 2011
Start date
Aug 2010
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Mar 26, 2012

Study contacts

Baharak Moshiree, MD, MS
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion