Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

Not Applicable

Completed

• Conditions: Colic; Gastrointestinal Diseases
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus reuteri DSM 17938; Drug: ampicillin and gentamicin

• Registration Number: NCT02865564
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed Description

The study is double-blind, placebo-controlled randomised trial and is composed from two parts. First part of the study aims to examine any difference in gut microbiota after postnatal antibiotic administration between the neonates who received probiotic Lactobacillus reuteri DSM 17938 or placebo and to compare the gut microbiota of patients to microbiota of healthy newborns. Second part of the study aims to determine whether probiotic L. reuteri DSM 17938 supplementation to antibiotic therapy has any beneficial influence on incidence of functional gastrointestinal disorders of infancy and body composition and bone density 6 weeks and one year after inclusion in the study.

Additionally the associations of the clinical parameters with the composition and developmental characteristics of fecal microbiota during antibiotic treatment in children will be evaluated; relevant clinical data such as mode of delivery, child's nutrition, health problems, growth and developmental attributes which could be found associated with fecal microbial community, will be tracked and statistically evaluated for the investigated population.

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Study Start: 2016-11
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo group will receive 5 drops of maltodextrin in the some oil suspension a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
Placebo group	ampicillin and gentamicin	Placebo group will receive 5 drops of maltodextrin in the some oil suspension a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
Intervention group	ampicillin and gentamicin	The intervention group will receive 5 drops, a minimum of 100 million live Lactobacillus reuteri DSM 17938 a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
Intervention group	Lactobacillus reuteri DSM 17938	The intervention group will receive 5 drops, a minimum of 100 million live Lactobacillus reuteri DSM 17938 a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.

Primary Outcome Measures

Name	Time	Method
Functional gastrointestinal dysfunction	At 6 months of age	Questionnaire \[/\]
Composition of gut microbiota in infants - 1	At 6 weeks after intervention	\[colony-forming units/ml; /\]
Infants crying duration time	At 6 months of age	Questionnaire \[/\]
Composition of gut microbiota in infants - 2	At one year of age	\[colony-forming units/ml; /\]

Secondary Outcome Measures

Name	Time	Method
Bone mineral density in infants - 1	At 6 months of age	Z-score \[/\]
Bone mineral density in infants - 2	At 12 months of age	Z-score \[/\]
Infant weight - 1	At 6 months of age	\[kg\]; to calculate body mass index
Infant weight - 2	At 12 months of age	\[kg\]; to calculate body mass index
Body composition of infants - 1	At 6 months of age
Infant height - 1	At 6 months of age	\[m\]; to calculate body mass index
Infant height - 2	At 12 months of age	\[m\]; to calculate body mass index
Body composition of infants - 2	At 12 months of age

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia