Hydrogen and Methane Breath Test Questionnaire

Completed

• Conditions: Small Intestinal Bacterial Overgrowth

• Registration Number: NCT05122520
• Lead Sponsor: The Functional Gut Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Primary Completion: 2023-03-26
• Study Completion: 2023-04-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1040

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine positive predictive symptoms for SIBO positive participants determined by HMBT	At same time as breath test	Using the HMBTQ

Secondary Outcome Measures

Name	Time	Method
Determine the frequency of recognised and potential risk factors in SIBO positive participants	At the same time as the breath test	Using the HMBTQ
Determine positive predictive symptoms for excessive methane positive participants determined by HMBT	At same time as the breath test	Using the HMBTQ
Determine the frequency of recognised and potential risk factors in excessive methane positive participants	At the same time as the breath test	Using the HMBTQ

Trial Locations

Locations (1)

The Functional Gut Clinic; 🇬🇧 Manchester, Greater Manchester, United Kingdom