Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05674318
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2022-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Alpha-lactalbumin on Microbiota Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007768', 'term': 'Lactalbumin'}], 'ancestors': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of microbiota composition', 'timeFrame': 'Change from baseline microbiota composition to 30 days of treatment', 'description': 'Determination of bacterial biodiversity by metagenomics approach'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alpha-lactalbumin', 'Microbiota', 'Dysbiosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* condition of dysbiosis\n\nExclusion Criteria:\n\n* antibiotic treatment within 1 month\n* probiotic or prebiotic treatments\n* concomitant inflammatory intestinal diseases\n* pregnancy\n* neoplastic diseases\n* allergy to milk protein (Alpha-lactalbumin)\n* substance abuse'}, 'identificationModule': {'nctId': 'NCT05674318', 'briefTitle': 'The Effect of Alpha-lactalbumin on Microbiota Composition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lo.Li.Pharma s.r.l'}, 'officialTitle': 'Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition', 'orgStudyIdInfo': {'id': 'PREBIO_LAC22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alpha-lactalbumin', 'interventionNames': ['Dietary Supplement: Alpha-lactalbumin']}], 'interventions': [{'name': 'Alpha-lactalbumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days', 'armGroupLabels': ['Alpha-lactalbumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01100', 'city': 'Viterbo', 'state': 'Rome', 'country': 'Italy', 'facility': 'Centro Polispecialistico Giovanni Paolo I°', 'geoPoint': {'lat': 42.41937, 'lon': 12.1056}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lo.Li.Pharma s.r.l', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}