Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT01855269
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2013-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003448', 'term': 'Crying'}, {'id': 'D003085', 'term': 'Colic'}], 'ancestors': [{'id': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-15', 'studyFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2013-05-15', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Crying time', 'timeFrame': '3 weeks', 'description': 'Infants crying episodes, feeding and stooling characteristics, growth, weight gain were noted weekly for three weeks'}], 'secondaryOutcomes': [{'measure': 'postpartum depression', 'timeFrame': '3 weeks', 'description': "Emotional structures of mother's behaviour were evaluated before and at 2nd month with Edinburgh postpartum depression scale (EPDS), State Trait Anxiety Inventory (STAI) tests."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['probiotic', 'infantile colic'], 'conditions': ['Crying']}, 'referencesModule': {'references': [{'pmid': '17200238', 'type': 'RESULT', 'citation': 'Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.'}]}, 'descriptionModule': {'briefSummary': 'The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.', 'detailedDescription': 'Infantile colic ıs one of the most common problems within the first 3 months of life, affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome characterized by paroxysmal, excessive, inconsolable crying without identifiable cause. Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults, and recent data demonstrated safety after long-term dietary supplementation for newborn infants. The positive effects of this probiotic on intestinal disorders such as constipation and diarrhea and in protection from infection,as well as its capacity to modulate immune responses.\n\nThe aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '3 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants three weeks to three months\n* infants with colic three hours of crying on three days in the week\n* infants feeding with breast milk\n* infants weighing 2500 to 4000 gram\n\nExclusion Criteria:\n\n* chronic illness\n* gastrointestinal disorders\n* infants received either antibiotics or probiotics in the previous week'}, 'identificationModule': {'nctId': 'NCT01855269', 'briefTitle': 'Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': "Dr. Sami Ulus Children's Hospital"}, 'officialTitle': 'A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic', 'orgStudyIdInfo': {'id': '134/Feb 2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactobacillus reuteri', 'description': 'Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Herbal drop', 'description': 'Herbal drop containing sodium bicarbonate, Pimpinella anisum oil, foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks', 'interventionNames': ['Dietary Supplement: Herbal drop']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sterile water', 'description': 'Sterile water: 5 drops, 30 minutes after feeding, once per day for 3 weeks', 'interventionNames': ['Dietary Supplement: placebo sterile water']}], 'interventions': [{'name': 'Lactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Biogaia'], 'description': 'Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks', 'armGroupLabels': ['Lactobacillus reuteri']}, {'name': 'Herbal drop', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Babs'], 'description': 'Herbal drop containing sodium bicarbonate, Pimpinella anisum oil,foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks', 'armGroupLabels': ['Herbal drop']}, {'name': 'placebo sterile water', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Sterile water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06120', 'city': 'Ankara', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Sami Ulus CH', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Nilgün Karadağ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD, Sami Ulus CH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Sami Ulus Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Dilek Dilli', 'investigatorAffiliation': "Dr. Sami Ulus Children's Hospital"}}}}