Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-02-28 @ 10:03 PM
Study NCT ID:
NCT03701906
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Mixture of New Probiotic Strains in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-10-08', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.', 'timeFrame': '2 months', 'description': 'Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Infant']}, 'referencesModule': {'references': [{'pmid': '35221319', 'type': 'DERIVED', 'citation': "Moreno-Sanz B, Montes MT, Manzano S, Espinosa-Martos I, Cardenas N, Esteban S, Cruz M, Jimenez E, de Pipaon MS. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):e153-e159. doi: 10.1097/MPG.0000000000003427. Epub 2022 Feb 25."}]}, 'descriptionModule': {'briefSummary': 'An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \\& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.\n\nThe study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.', 'detailedDescription': 'An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \\& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.\n\nThe duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '1 Minute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation.\n* Written informed consent signed by the parent or legal guardian.\n* Tolerate enteral feeding, at least 10mL / kg / day.\n* Postnatal age ≤ 5 days\n\nExclusion Criteria:\n\n* Child with malformations\n* With short bowel syndrome or any surgery in the gastrointestinal tract\n* With defect in the intestinal epithelial barrier'}, 'identificationModule': {'nctId': 'NCT03701906', 'acronym': 'PREBIOMA', 'briefTitle': 'Effect of a Mixture of New Probiotic Strains in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProbiSearch SL'}, 'officialTitle': 'Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.', 'orgStudyIdInfo': {'id': 'PRE/18.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactobacillus PS11603 & Bifidobacterium PS10402', 'description': 'A mixture of 1\\*10E9 colony forming unit (CFU) of Lactobacillus PS11603 and 1\\*10E8 CFU of Bifidobacterium PS10402 in 1 vial will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age.', 'interventionNames': ['Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': '1 vial of Placebo will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus PS11603 & Bifidobacterium PS10402', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeks'], 'description': 'Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1\\*10E9 CFU of L.salivarius PS11603 and 1\\*10E8 CFU of B.longum PS10402.', 'armGroupLabels': ['Lactobacillus PS11603 & Bifidobacterium PS10402']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Susana Manzano, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ProbiSearch SL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProbiSearch SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}