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.
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.
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.
- Conditions
- Malabsorption Syndromes
- 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 group | Role | What they receive |
|---|---|---|
| Breath test | Subjects 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.
13CO2 enrichment in breath CO2
Measured: 3 hours
Secondary outcomes (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.
- First posted31 Mar 2009 (estimated)
- Study startOct 1997
- Primary completionSep 1998
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malabsorption SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Heiner K. Berthold, MD, PhD, Principal investigator, University of Bonn
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Breath Tests in Diagnosing Small Bowel Bacterial Overgrowth
- ClinicalTrials.gov ID
- NCT00872092
- Acronym / sponsor ID
- BTO / BTO-0001
- Conditions
- Malabsorption Syndromes
- Keywords
- small bowel, bacterial overgrowth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Oct 1997
- Primary completion
- Sep 1998 (actual)
- Study completion
- Sep 1998 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath test | – | Other: Stable-isotope labeled lactose ureide breath testSubjects with suspected SBBO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected small bowel bacterial overgrowth
Key inclusion criteria (1 listed)
- Suspected small bowel bacterial overgrowth
Key exclusion criteria (2 listed)
- Age < 18 years
- Antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable-isotope labeled lactose ureide breath testAlso: Lactosyl ureide2 g 13C-labeled lactose ureide orally | Other | Breath test |
Primary outcome
13CO2 enrichment in breath CO2
Time frame: 3 hours
1 secondary outcome
Hydrogen output in breath
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiner K. Berthold, MD, PhD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
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.