Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT03467334
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2018-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infant Colic Treatment With Probiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2018-03-09', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Crying time', 'timeFrame': '4 weeks', 'description': 'Crying time in minutes per day'}], 'secondaryOutcomes': [{'measure': 'Responders to treatment on weeks 1, 2, 3 and 4', 'timeFrame': '4 weeks', 'description': 'Number of responders to the treatment in each group on weeks 1, 2, 3 and 4. It is understood that responders are those infants who have experienced a daily decrease in the duration of the crises cries 50% above baseline'}, {'measure': 'Gut microbiota', 'timeFrame': '4 weeks', 'description': 'Effect of the treatment on intestinal microbiota: the levels of Escherichia coli, Clostridium, Bacteroides, Lactobacillus and Bifidobacterium at the beginning and at the end of the study (weeks 0 and 4) will be analyzed by quantitative PCR.'}, {'measure': 'Stool carbohydrates', 'timeFrame': '4 weeks', 'description': 'Stool carbohydrate levels: lactose and other carbohydrate levels will be analyzed by chromatography (Triple Quad LC/MS) at the beginning and end of the study (weeks 0 and 4).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infant colic', 'Bifidobacterium breve', 'Lactobacillus fermentum'], 'conditions': ['Infant Colic']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.', 'detailedDescription': 'Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.\n\nThe objective of the present study is to compare the effect of B. brevis and B. brevis\\\\L mixture. fermentum with respect to simethicone.\n\nIt is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '3 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants from 3 to 12 weeks of age\n* Born at least at week 34\n* Birth weight equal to or greater than 2000 grams\n* Fulfill the criteria of Rome III\n* Informed consent signed by parents or guardians\n\nExclusion Criteria:\n\n* Failure to thrive\n* Antibiotic treatment less than 2 weeks before the study or during the study\n* Take probiotics as a treatment, different from the one that could contain the powdered infant formula\n* Abandon breastfeeding and switch to infant formula\n* Failure to comply with the study protocol'}, 'identificationModule': {'nctId': 'NCT03467334', 'briefTitle': 'Infant Colic Treatment With Probiotics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosearch S.A.'}, 'officialTitle': 'Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic', 'orgStudyIdInfo': {'id': 'P040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B. breve', 'description': 'Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water.', 'interventionNames': ['Dietary Supplement: B. breve']}, {'type': 'EXPERIMENTAL', 'label': 'B. breve plus L. fermentum', 'description': 'Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water.', 'interventionNames': ['Dietary Supplement: B. breve plus L. fermentum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simethicone 20 mg', 'description': 'Control group that will receive simethicone 4 times (10 drops) a day.', 'interventionNames': ['Drug: Simethicone 20 MG']}], 'interventions': [{'name': 'B. breve', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Bifidobacterium probiotic strain at 1E+08 cfu/day', 'armGroupLabels': ['B. breve']}, {'name': 'B. breve plus L. fermentum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic combination at 2E+08 cfu/day', 'armGroupLabels': ['B. breve plus L. fermentum']}, {'name': 'Simethicone 20 MG', 'type': 'DRUG', 'description': 'Standard treatment for infant colic', 'armGroupLabels': ['Simethicone 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Servicio Andaluz de Salud', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'José Maldonado, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mónica Olivares Martín; PhD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'European Regional Development Fund', 'class': 'OTHER'}, {'name': 'Ministerio de Ciencia e Innovación, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of the R & D Department', 'investigatorFullName': 'Mónica Olivares Martín; PhD', 'investigatorAffiliation': 'Biosearch S.A.'}}}}