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Malabsorption SyndromesBTONCT00872092

Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth

An observational study of Malabsorption Syndromes, run by University Hospital, Bonn at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malabsorption Syndromes
What is being tested?
Stable-isotope labeled lactose ureide breath test
Type of treatment
Pill or oral medicine
How many people
22 participants
Where
1 siteGermany
Study dates
Oct 1997to Sep 1998
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with suspected small bowel bacterial overgrowth

Who may be able to join

  • Suspected small bowel bacterial overgrowth

Who cannot join

  • Age < 18 years
  • Antibiotic therapy

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University of Bonn

    Bonn, 53105

Other trials in Germany

About this study

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.

Being tested
Stable-isotope labeled lactose ureide breath test
Keywords
small bowel, bacterial overgrowth
Medical subject headings
Malabsorption Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stable-isotope labeled lactose ureide breath testOther

    Also called Lactosyl ureide

    2 g 13C-labeled lactose ureide orally

Study groups in NCT00872092
Study groupRoleWhat they receive
Breath testSubjects with suspected SBBO
Receives: Other: Stable-isotope labeled lactose ureide breath test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 13CO2 enrichment in breath CO2

    Measured: 3 hours

Secondary outcomes (1)
  1. Hydrogen output in breath

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2009 (estimated)
  2. Study startOct 1997
  3. Primary completionSep 1998
  4. Study completionSep 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00872092
Sponsor's protocol ID
BTO-0001
Acronym
BTO
Status last verified
Mar 2009
First submitted
30 Mar 2009
Last updated
31 Mar 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Malabsorption Syndromes, run by University Hospital, Bonn at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

13CO2 enrichment in breath CO2 (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.

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