Small Intestinal Bacterial OvergrowthHMBTQNCT05122520
Hydrogen and Methane Breath Test Questionnaire
An observational study of Small Intestinal Bacterial Overgrowth, run by The Functional Gut Clinic at 1 site in United Kingdom.
Trial summary
Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth
- What is being tested?
- Questionnaire
- How many people
- 1,040 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2021to 26 Apr 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All eligible patients referred for Glucose and Lactulose HMBT at the Functional Gut Clinic will be approached to see if they would like to take part in this study
Who may be able to join
- Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic
- Participant has capacity to understand written English
- Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Functional Gut Clinic
Manchester, Greater Manchester, M3 4BG
About this study
Official title: A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes
Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production.
Recently there has been a lot of work to done by experts in the field, to ensure that performance and interpretation of these tests are standardised, to help improve the clinical utility of these investigations. Although there is a lot of information currently available demonstrating the risk factors and symptoms associated with these conditions, there is a lack of data demonstrating the factors that might lead to a positive test according to these new parameters. This study aims to collect data on symptoms and medical history, in patients referred for lactulose and glucose HMBT in order further improve the effectiveness of this test in the future.
- Conditions
- Small Intestinal Bacterial Overgrowth
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The HMBT-Q is a 26-item questionnaire, split into four main sections: food related symptoms; general digestive symptoms; extra-intestinal symptoms and co-morbidities and Medication and onset.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine positive predictive symptoms for SIBO positive participants determined by HMBT
Using the HMBTQ
Measured: At same time as breath test
Secondary outcomes (3)
Determine positive predictive symptoms for excessive methane positive participants determined by HMBT
Using the HMBTQ
Measured: At same time as the breath test
Determine the frequency of recognised and potential risk factors in SIBO positive participants
Using the HMBTQ
Measured: At the same time as the breath test
Determine the frequency of recognised and potential risk factors in excessive methane positive participants
Using the HMBTQ
Measured: At the same time as the breath test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start10 Feb 2021
- Primary completion26 Mar 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Functional Gut Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anthony Hobson, The Functional Gut Clinic
- Investigators
- Anthony Hobson, Principal investigator, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122520
- Sponsor's protocol ID
- FGC-20-003
- Acronym
- HMBTQ
- Status last verified
- Jun 2023
- First submitted
- 4 Nov 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes
- ClinicalTrials.gov ID
- NCT05122520
- Acronym / sponsor ID
- HMBTQ / FGC-20-003
- Conditions
- Small Intestinal Bacterial Overgrowth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- The Functional Gut ClinicUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- 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.
Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production.
Recently there has been a lot of work to done by experts in the field, to ensure that performance and interpretation of these tests are standardised, to help improve the clinical utility of these investigations. Although there is a lot of information currently available demonstrating the risk factors and symptoms associated with these conditions, there is a lack of data demonstrating the factors that might lead to a positive test according to these new parameters. This study aims to collect data on symptoms and medical history, in patients referred for lactulose and glucose HMBT in order further improve the effectiveness of this test in the future.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients referred for Glucose and Lactulose HMBT at the Functional Gut Clinic will be approached to see if they would like to take part in this study
Key inclusion criteria (3 listed)
- Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic
- Participant has capacity to understand written English
- Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QuestionnaireThe HMBT-Q is a 26-item questionnaire, split into four main sections: food related symptoms; general digestive symptoms; extra-intestinal symptoms and co-morbidities and Medication and onset. | Other | – |
Primary outcome
Determine positive predictive symptoms for SIBO positive participants determined by HMBT
Time frame: At same time as breath test
Using the HMBTQ
3 secondary outcomes
Determine positive predictive symptoms for excessive methane positive participants determined by HMBT
Time frame: At same time as the breath test
Determine the frequency of recognised and potential risk factors in SIBO positive participants
Time frame: At the same time as the breath test
Determine the frequency of recognised and potential risk factors in excessive methane positive participants
Time frame: At the same time as the breath test
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 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Anthony Hobson principal investigator
The Functional Gut Clinic
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 Small Intestinal Bacterial Overgrowth, run by The Functional Gut Clinic at 1 site in United Kingdom.
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 3 inclusion and 0 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 2 Jun 2023. 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 United Kingdom. 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?
Determine positive predictive symptoms for SIBO positive participants determined by HMBT (time frame: At same time as breath test). 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 2 Jun 2023.