Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-28 @ 3:59 AM
Study NCT ID:
NCT01568567
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2012-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-03', 'studyFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measured by blood chemistry parameters', 'timeFrame': '28 days', 'description': 'To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.'}, {'measure': 'Tolerability measured by blood chemistry parameters', 'timeFrame': '28 days', 'description': 'To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'tolerance', 'lactobacillus Reuteri'], 'conditions': ['Safety']}, 'descriptionModule': {'briefSummary': 'Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.\n\nAlthough the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Age 18-65 years at visit 1\n* BMI 19-29\n* Hb ≥ 120 g/l for women and ≥ 130 g/l for men\n* Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD\n* Signed informed consent and biobank consent\n\nExclusion Criteria:\n\n* Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study\n* Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.\n* Pregnant or lactating or wish to become pregnant during the period of the study.\n* Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.'}, 'identificationModule': {'nctId': 'NCT01568567', 'acronym': 'BSSII', 'briefTitle': 'Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Good Food Practice, Sweden'}, 'officialTitle': 'To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study', 'orgStudyIdInfo': {'id': 'CSP U-11-008'}, 'secondaryIdInfos': [{'id': 'CSUB0031', 'type': 'OTHER_GRANT', 'domain': 'Biogaia AB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double dose', 'description': 'One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide', 'interventionNames': ['Dietary Supplement: Lactobacillus Reuteri DSM 17938']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single dose', 'description': 'One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide', 'interventionNames': ['Dietary Supplement: Lactobacillus Reuteri DSM 17938']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide', 'interventionNames': ['Dietary Supplement: Lactobacillus Reuteri DSM 17938']}], 'interventions': [{'name': 'Lactobacillus Reuteri DSM 17938', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One stick pack in the morning and one stick pack afternoon/evening for 28 days.', 'armGroupLabels': ['Double dose', 'Placebo', 'Single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751 83', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Good Food Practice Uppsala', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Johan Olsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KPL Good Food Practice AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Good Food Practice, Sweden', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioGaia AB', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}