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Completed

NCT Number: NCT05122520

Hydrogen and Methane Breath Test Questionnaire

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.

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Key information

Conditions

Small Intestinal Bacterial Overgrowth

Sex eligibility

All sexes

Study type

Observational

Primary location

The Functional Gut Clinic

Manchester, Greater Manchester, M3 4BG, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. Determine positive predictive symptoms for SIBO positive participants determined by HMBT

    Time frame: At same time as breath test

    Using the HMBTQ

Secondary outcomes

  1. Determine positive predictive symptoms for excessive methane positive participants determined by HMBT

    Time frame: At same time as the breath test

    Using the HMBTQ

  2. Determine the frequency of recognised and potential risk factors in SIBO positive participants

    Time frame: At the same time as the breath test

    Using the HMBTQ

  3. Determine the frequency of recognised and potential risk factors in excessive methane positive participants

    Time frame: At the same time as the breath test

    Using the HMBTQ

Sponsors and collaborators

Lead sponsor

The Functional Gut Clinic

Other

Registry information

Official study title

A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes

Acronym: HMBTQ

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2021
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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