Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Unknown status

CT.gov ID

NCT02865564

Collaborator

University of Ljubljana (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Diseases Colic	Dietary Supplement: Lactobacillus reuteri DSM 17938 Dietary Supplement: Placebo Drug: ampicillin and gentamicin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention group 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.	Dietary Supplement: Lactobacillus reuteri DSM 17938 Other Names: BioGaia Drug: ampicillin and gentamicin
Placebo Comparator: Placebo group 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.	Dietary Supplement: Placebo Drug: ampicillin and gentamicin

Arm

Intervention/Treatment

Active Comparator: Intervention group

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.

Dietary Supplement: Lactobacillus reuteri DSM 17938

Other Names:

BioGaia

Drug: ampicillin and gentamicin

Placebo Comparator: Placebo group

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.

Dietary Supplement: Placebo

Drug: ampicillin and gentamicin

Outcome Measures

Primary Outcome Measures

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; /]