Hydrogen and Methane Breath Test Questionnaire (HMBTQ)

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.

Study Overview

• Status: Completed
• Conditions: Small Intestinal Bacterial Overgrowth
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 1040

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M3 4BG
      • The Functional Gut Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine positive predictive symptoms for SIBO positive participants determined by HMBT	Using the HMBTQ	At same time as breath test

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Functional Gut Clinic
• Investigators: Principal Investigator: Anthony Hobson, The Functional Gut Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FGC-20-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No