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Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth (BTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872092
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : March 31, 2009
Information provided by:
University Hospital, Bonn

Brief Summary:
Normally the gastrointestinal tract is only sparsely colonized with bacteria. The normal flora of the duodenal or jejunal aspirate contains no more than 10^5 bacteria per milliliter. Small bowel bacterial overgrowth (SBBO) is defined as a pathologically increased number of bacteria or the presence of colonic flora in the proximal intestine. The reasons for this condition are manifold, ranging from diabetic neuropathy to surgical bypass. SBBO is frequent in elderly people. Therapy is targeted at correcting the underlying small bowel abnormalities that predispose to the condition and at providing appropriate antibiotic therapy. The symptoms and signs of SBBO can be reversed with this approach. However, in many patients the conditions predisposing to SBBO persist life-long, once present. This suggests that noninvasive, sensitive diagnostic tools with high specificity are required. Bacterial culture of upper intestinal content is considered the diagnostic gold standard. However, since endoscopic harvesting of duodenal or jejunal fluid is difficult and invasive, indirect tests such as breath tests have been advocated as diagnostic tools. Hydrogen breath tests are commonly employed since the substrates can be easily obtained and the measurement is simple. Hydrogen is formed when carbohydrates are fermented in the intestine. Breath hydrogen analysis allows a separation of metabolic activity of the intestinal flora from that of the host, since no known hydrogen production occurs in mammalian tissue. The hydrogen breath test most often used in routine clinical practice uses glucose. However, the utility of this test is mostly limited by its low sensitivity, because there are "nonproducers" in up to 25% of the subjects tested. The investigators have developed a stable isotope breath test using 13C-labeled lactose-ureide. Glycosyl-ureides are condensation products of reducing sugars and urea in aqueous acid. Lactose-[13C]ureide has been used to investigate oro-caecal transit time because it resists digestion by small intestinal enzymes and is hydrolyzed by bacterial enzymes in the large intestine. A number of studies have described the use of this substrate in adults and children. The aim of the present study was to investigate the lactose-[13C]ureide breath test in subjects with suspected SBBO and to compare its results with the results of the glucose hydrogen breath test. Microbiological analyses of upper intestinal bacterial cultures were used as gold standard to identify SBBO.

Condition or disease Intervention/treatment
Malabsorption Syndromes Other: Stable-isotope labeled lactose ureide breath test

Study Type : Observational
Actual Enrollment : 22 participants
Official Title: Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth
Study Start Date : October 1997
Primary Completion Date : September 1998
Study Completion Date : September 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Breath test
Subjects with suspected SBBO
Other: Stable-isotope labeled lactose ureide breath test
2 g 13C-labeled lactose ureide orally
Other Name: Lactosyl ureide

Primary Outcome Measures :
  1. 13CO2 enrichment in breath CO2 [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Hydrogen output in breath [ Time Frame: 3 hours ]

Biospecimen Retention:   Samples Without DNA
Breath samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected small bowel bacterial overgrowth

Inclusion Criteria:

  • Suspected small bowel bacterial overgrowth

Exclusion Criteria:

  • Age < 18 years
  • Antibiotic therapy

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 identifier (NCT number): NCT00872092

University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Principal Investigator: Heiner K. Berthold, MD, PhD University of Bonn

Responsible Party: Heiner K. Berthold, University of Bonn - Germany Identifier: NCT00872092     History of Changes
Other Study ID Numbers: BTO-0001
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by University Hospital, Bonn:
small bowel
bacterial overgrowth

Additional relevant MeSH terms:
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases