Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05735418
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2023-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A double-blind, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Walking speed', 'timeFrame': '0, 2, 4, 8 weeks', 'description': 'The time to walk a 10-m distance will be measured.'}, {'measure': 'Gut quotient', 'timeFrame': '0, 2, 4, 8 weeks', 'description': 'Gut quotient measurement scales will be asked using questionnaires. The minimum and maximum values are 0 and 100, respectively. Higher scores are related to worse gut quotient.'}, {'measure': 'IGF-1', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "IGF-1 will be quantified from the participants' serum samples."}, {'measure': 'Myostatin', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "Myostatin will be quantified from the participants' serum samples."}, {'measure': '8-OHdG', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "8-OHdG will be quantified from the participants' serum samples."}, {'measure': 'Fecal acetate level', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "Acetate level (short-chain fatty acid) will be measured from the participants' stool."}, {'measure': 'Fecal butyrate level', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "Butyrate level (short-chain fatty acid) will be measured from the participants' stool."}, {'measure': 'Fecal propionate level', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "Propionate level (short-chain fatty acid) will be measured from the participants' stool."}, {'measure': 'Fecal calproate level', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "Calproate level (short-chain fatty acid) will be measured from the participants' stool."}, {'measure': 'Fecal valerate level', 'timeFrame': '0, 2, 4, 8 weeks', 'description': "Valerate level (short-chain fatty acid) will be measured from the participants' stool."}], 'primaryOutcomes': [{'measure': 'Hand Grip Strength Change', 'timeFrame': '4 weeks', 'description': 'Change from baseline hand grip strength at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Bacteroidetes/Firmicutes Ratio Change', 'timeFrame': '4 weeks', 'description': 'Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks'}, {'measure': 'Fasting blood glucose', 'timeFrame': '4 weeks', 'description': 'Change from baseline fasting blood glucose at 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiome', 'probiotics', 'muscle strength', 'intervention'], 'conditions': ['Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of probiotics named GI Biome #7 on the gut microbiome and muscle strength in older adults aged 60 years or older.', 'detailedDescription': "This study is a double-blind, randomized controlled trial. A total of 60 healthy adults aged 60 years or older will be recruited, and they will be randomly assigned to the intervention group or the control group. The intervention group will be given GI Biome #7 pills, and the control group will be given the placebo pills for four weeks. The participants will visit the research laboratory four times as follows: A day before starting to take the pills, two weeks later after starting to take the pills, the last day of taking the pills, and four weeks later after the end of taking the pills. Participants' stool, blood, and urine will be sampled every visit, and grip strength and body composition will also be checked."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years old or older\n* Those who have no difficulties in daily living\n* Willing to commit throughout the study\n\nExclusion Criteria:\n\n* Antibiotics medication in the last month.\n* Probiotics used in the last months.\n* Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke'}, 'identificationModule': {'nctId': 'NCT05735418', 'briefTitle': 'The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Study on the Effects of Oral Intake of GI Biome #7 on the Intestinal Microbiome and Health in the Elderly Population', 'orgStudyIdInfo': {'id': 'GIB-2022-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GI Biome #7', 'description': 'The intervention consists of daily administration of probiotics GI Biome #7 for four weeks.', 'interventionNames': ['Dietary Supplement: GI Biome #7']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'GI Biome #7', 'type': 'DIETARY_SUPPLEMENT', 'description': 'It comprises probiotics (Lactobacillus fermentum, Lactobacillus acidophilus, Lactobacillus plantarum, and Bifidobacterium animalis ssp. lactis) and prebiotics (vitamin B2., Korean red ginseng, and etc.). The administration dosage of probiotics is 5×10\\^8 CFU/day.', 'armGroupLabels': ['GI Biome #7']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yun-Chul Hong, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'GI Biome', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yun-Chul Hong', 'investigatorAffiliation': 'Seoul National University'}}}}