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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2023
Source The Functional Gut Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms

  • Small Intestinal Bacterial Overgrowth

Intervention

Other:
Questionnaire
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.

Locations

Country Name City State
United Kingdom The Functional Gut Clinic Manchester Greater Manchester

Sponsors (1)

Lead Sponsor Collaborator
The Functional Gut Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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