Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-28 @ 3:46 AM
Study NCT ID:
NCT04873466
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Enzyme-rich Malt Extract on Chronic Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label, single arm'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Cohort'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in constipation score', 'timeFrame': '35 days', 'description': 'according to Knowels-Eccersley-Scott Symptom (KESS) score (likert scale of 0-3/4 with maximum score 39). Higher score = more severe'}], 'secondaryOutcomes': [{'measure': 'Change in stool frequency', 'timeFrame': '35 days', 'description': 'according to number of weekly bowel movements'}, {'measure': 'Change in breath methane levels', 'timeFrame': '35 days', 'description': 'fasting breath methane levels (ppm)'}, {'measure': 'Change in bloating', 'timeFrame': '35 days', 'description': 'according to daily visual analog scale'}, {'measure': 'Change in abdominal pain', 'timeFrame': '35 days', 'description': 'according to daily visual analog scale'}, {'measure': 'Change in flatulence', 'timeFrame': '35 days', 'description': 'according to daily visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Constipation'], 'conditions': ['Constipation', 'Quality of Life', 'Methane Production']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://functionalgutdiagnostics.com/clinical-research/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.', 'detailedDescription': 'This pilot study is an open label, pre-post interventional study to evaluate the use of ERME in the treatment of people with chronic constipation.\n\nThis study involves eligible participants that have a diagnosis constipation according to the Knowles-Eccersley-Scott Score (KESS). Participants will receive intervention with a food supplement enzyme-rich malt extract (ERME) at a dose of 15ml twice daily with food.\n\nBefore intervention commences, participants will complete baseline breath samples and a 7 day stool diary to assess stool frequency and consistency.\n\nParticipants will then receive the ERME as instructed and continue to complete a bowel diary. Then at 4 weeks since starting the intervention, participants will provide another breath sample and complete another set of breath samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has diagnosis of chronic constipation according to the KESS score.\n* Participant can communicate and understand English.\n* Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).\n\nExclusion Criteria:\n\n* Dependant use of opioid-based medications.\n* New use of prokinetic therapy during the study.\n* Use of antibiotics in the last 4 weeks.\n* Use of probiotics in the last 2 weeks.\n* Organic gastrointestinal disease, including inflammatory bowel disease (IBD), coeliac disease and diverticulitis.\n* Participant has known mechanical obstruction of the GI tract.\n* Participant has diabetes.\n* Participant has any hepatic disease.\n* Participant has any disease of the CNS.\n* Participant has had previous abdominal or colorectal surgery including appendectomy, cholecystectomy, and hysterectomy.\n* Participant has intake of ERME for 2 weeks before the study.'}, 'identificationModule': {'nctId': 'NCT04873466', 'briefTitle': 'The Effects of Enzyme-rich Malt Extract on Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'The Functional Gut Clinic'}, 'officialTitle': 'The Effects of Enzyme-rich Malt Extract on Symptoms of Chronic Constipation', 'orgStudyIdInfo': {'id': 'FGC-20-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enzyme-rich malt extract', 'description': 'Enzyme-rich malt extract (15 ml b.i.d with food)', 'interventionNames': ['Dietary Supplement: Enzyme-rich malt extract']}], 'interventions': [{'name': 'Enzyme-rich malt extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Enzyme-rich malt extract (ERME) is a by-product of the malting process in which the cereal grain barley is dried. The ingredients are 100% barley malt extract. It smells and tastes sweet, with a runny jam-like texture. Malt extract has been used as a food stuff in baking and cookery for many years, but ERME is extracted by means which retains more active enzymes, such as amylase.', 'armGroupLabels': ['Enzyme-rich malt extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2 4NG', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Functional Gut Clinic', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Functional Gut Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Physiologist', 'investigatorFullName': 'Jordan Haworth', 'investigatorAffiliation': 'The Functional Gut Clinic'}}}}