Hydrogen and Methane Breath Test Questionnaire | NCT05122520

Studies
Hydrogen and Methane Breath Test Questionnaire

NCT05122520

Sponsor

The Functional Gut Clinic

Status

Completed

Last Update Posted

Jun 2, 2023Actual

Enrollment

1,040Actual

Phase

Not provided

Conditions

Small Intestinal Bacterial Overgrowth

Interventions

Questionnaire

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2021Actual

Primary Completion Date

Mar 26, 2023Actual

Completion Date

Apr 26, 2023Actual

First Submitted Date

Nov 4, 2021

First Submission Date that Met QC Criteria

Nov 4, 2021

First Posted Date

Nov 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2023

Last Update Posted Date

Jun 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,040Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Hobson	The Functional Gut Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Functional Gut Clinic		Manchester	Greater Manchester	M3 4BG	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided