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Hydrogen and Methane Breath Test Questionnaire

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05122520
Acronym
HMBTQ
Enrollment
1040
Registered
2021-11-16
Start date
2021-02-10
Completion date
2023-04-26
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Intestinal Bacterial Overgrowth

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.

Interventions

OTHERQuestionnaire

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.

Sponsors

The Functional Gut Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
Determine positive predictive symptoms for SIBO positive participants determined by HMBTAt same time as breath testUsing the HMBTQ

Secondary

MeasureTime frameDescription
Determine positive predictive symptoms for excessive methane positive participants determined by HMBTAt same time as the breath testUsing the HMBTQ
Determine the frequency of recognised and potential risk factors in SIBO positive participantsAt the same time as the breath testUsing the HMBTQ
Determine the frequency of recognised and potential risk factors in excessive methane positive participantsAt the same time as the breath testUsing the HMBTQ

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026