Small Intestinal Bacterial Overgrowth Clinical Trial
— HMBTQOfficial title:
A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes
NCT number | NCT05122520 |
Other study ID # | FGC-20-003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 10, 2021 |
Est. completion date | April 26, 2023 |
Verified date | June 2023 |
Source | The Functional Gut Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1040 |
Est. completion date | April 26, 2023 |
Est. primary completion date | March 26, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic 2. Participant has capacity to understand written English 3. Participant can communicate well with the Investigator and to comply with the requirements for the entire study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Functional Gut Clinic | Manchester | Greater Manchester |
Lead Sponsor | Collaborator |
---|---|
The Functional Gut Clinic |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine positive predictive symptoms for SIBO positive participants determined by HMBT | Using the HMBTQ | At same time as breath test | |
Secondary | Determine positive predictive symptoms for excessive methane positive participants determined by HMBT | Using the HMBTQ | At same time as the breath test | |
Secondary | Determine the frequency of recognised and potential risk factors in SIBO positive participants | Using the HMBTQ | At the same time as the breath test | |
Secondary | Determine the frequency of recognised and potential risk factors in excessive methane positive participants | Using the HMBTQ | At the same time as the breath test |
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