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

Primary Purpose

Malabsorption Syndromes

Status
Completed
Phase
Locations
Germany
Study Type
Observational
Intervention
Stable-isotope labeled lactose ureide breath test
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Malabsorption Syndromes focused on measuring small bowel, bacterial overgrowth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suspected small bowel bacterial overgrowth

Exclusion Criteria:

  • Age < 18 years
  • Antibiotic therapy

Sites / Locations

  • University of Bonn

Arms of the Study

Arm 1

Arm Type

Arm Label

Breath test

Arm Description

Subjects with suspected SBBO

Outcomes

Primary Outcome Measures

13CO2 enrichment in breath CO2

Secondary Outcome Measures

Hydrogen output in breath

Full Information

First Posted
March 30, 2009
Last Updated
March 30, 2009
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT00872092
Brief Title
Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth
Acronym
BTO
Official Title
Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth
Study Type
Observational

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
September 1998 (Actual)
Study Completion Date
September 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malabsorption Syndromes
Keywords
small bowel, bacterial overgrowth

7. Study Design

Enrollment
22 (Actual)
Biospecimen Retention
Samples Without DNA
Biospecimen Description
Breath samples

8. Arms, Groups, and Interventions

Arm Title
Breath test
Arm Description
Subjects with suspected SBBO
Intervention Type
Other
Intervention Name(s)
Stable-isotope labeled lactose ureide breath test
Other Intervention Name(s)
Lactosyl ureide
Intervention Description
2 g 13C-labeled lactose ureide orally
Primary Outcome Measure Information:
Title
13CO2 enrichment in breath CO2
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Hydrogen output in breath
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected small bowel bacterial overgrowth Exclusion Criteria: Age < 18 years Antibiotic therapy
Study Population Description
Patients with suspected small bowel bacterial overgrowth
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiner K. Berthold, MD, PhD
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany

12. IPD Sharing Statement

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Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth

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