Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05122520
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2021-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydrogen and Methane Breath Test Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1040}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine positive predictive symptoms for SIBO positive participants determined by HMBT', 'timeFrame': 'At same time as breath test', 'description': 'Using the HMBTQ'}], 'secondaryOutcomes': [{'measure': 'Determine positive predictive symptoms for excessive methane positive participants determined by HMBT', 'timeFrame': 'At same time as the breath test', 'description': 'Using the HMBTQ'}, {'measure': 'Determine the frequency of recognised and potential risk factors in SIBO positive participants', 'timeFrame': 'At the same time as the breath test', 'description': 'Using the HMBTQ'}, {'measure': 'Determine the frequency of recognised and potential risk factors in excessive methane positive participants', 'timeFrame': 'At the same time as the breath test', 'description': 'Using the HMBTQ'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Intestinal Bacterial Overgrowth']}, 'descriptionModule': {'briefSummary': '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.\n\nRecently 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic\n2. Participant has capacity to understand written English\n3. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.'}, 'identificationModule': {'nctId': 'NCT05122520', 'acronym': 'HMBTQ', 'briefTitle': 'Hydrogen and Methane Breath Test Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'The Functional Gut Clinic'}, 'officialTitle': 'A Questionnaire to Identify Predictive Symptoms and Risk Factors for Hydrogen and Methane Breath Testing Outcomes', 'orgStudyIdInfo': {'id': 'FGC-20-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3 4BG', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Functional Gut Clinic', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Anthony Hobson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Functional Gut Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Functional Gut Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Director', 'investigatorFullName': 'Dr Anthony Hobson', 'investigatorAffiliation': 'The Functional Gut Clinic'}}}}