Clinical trial

Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics on Emergence of Functional Gastrointestinal Disorders, Body Composition, Mineral Bone Density and Fecal Microbiota in Infancy

Name
UPKLjubljana
Description
The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.
Trial arms
Trial start
2016-11-01
Estimated PCD
2020-03-01
Trial end
2020-03-01
Status
Completed
Treatment
Lactobacillus reuteri DSM 17938
Arms:
Intervention group
Other names:
BioGaia
Placebo
Arms:
Placebo group
ampicillin and gentamicin
Arms:
Intervention group, Placebo group
Size
98
Primary endpoint
Functional gastrointestinal dysfunction
At 6 months of age
Composition of gut microbiota in infants - 1
At 6 weeks after intervention
Infants crying duration time
At 6 months of age
Composition of gut microbiota in infants - 2
At one year of age
Eligibility criteria
Inclusion Criteria: * term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection Exclusion Criteria: * gestational age under 37 weeks * birth weight less than 2500 grams * congenital malformations/syndromes * perinatal hypoxia * who had received probiotics before the randomization * have had cow's milk protein allergy diagnosed during the study * patient who will be treated with antibiotic for less than 5 days
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 98, 'type': 'ACTUAL'}}
Updated at
2024-01-30

1 organization

1 product

2 indications

Indication
Colic