Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth

Malabsorption Syndromes Clinical Trial

— BTO  

Official title:

Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872092
• Other study ID #: BTO-0001
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: October 1997
• Est. completion date: September 1998

Study information

• Verified date: March 2009
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 1998
• Est. primary completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected small bowel bacterial overgrowth

Exclusion Criteria:

• Age < 18 years

• Antibiotic therapy

Study Design

N/A

Related Conditions & MeSH terms

• Malabsorption Syndromes

Intervention

Other:
• Stable-isotope labeled lactose ureide breath test
2 g 13C-labeled lactose ureide orally

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	13CO2 enrichment in breath CO2		3 hours	No
Secondary	Hydrogen output in breath		3 hours	No