CompletedNot Applicable

Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

Slovenia98 participantsStarted 2016-11

Plain-language summary

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.

Who can participate

Age range21 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Functional gastrointestinal dysfunction

Timeframe: At 6 months of age

Composition of gut microbiota in infants - 1

Timeframe: At 6 weeks after intervention

Infants crying duration time

Timeframe: At 6 months of age

Composition of gut microbiota in infants - 2

Timeframe: At one year of age

Trial details

NCT IDNCT02865564

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03

View on ClinicalTrials.gov More Gastrointestinal Diseases trials