Hydrogen and Methane Breath Test Questionnaire

NCT05122520 | Completed

• 1 other identifier: FGC-20-003
• Study Type: observational
• Target: 1,040
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (1)

• Determine positive predictive symptoms for SIBO positive participants determined by HMBT

  Using the HMBTQ

  At same time as breath test

Secondary Outcomes (3)

• Determine positive predictive symptoms for excessive methane positive participants determined by HMBT

  At same time as the breath test

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

  At the same time as the breath test

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

  At the same time as the breath test

Interventions

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• The Functional Gut Clinic: lead

Study Sites (1)

The Functional Gut Clinic

Manchester, Greater Manchester, M3 4BG, United Kingdom

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anthony Hobson

  The Functional Gut Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: February 10, 2021
• Primary Completion: March 26, 2023
• Study Completion: April 26, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

GB (1)