Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Colic
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus reuteri DSM 17938; Drug: ampicillin and gentamicin

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimated): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; Gastrointestinal Microbiome; Randomized Controlled Trial; Gastrointestinal Diseases; Pediatrics; Body Composition; Infant, Newborn; ultrasonography; Colic; High-Throughput Nucleotide Sequencing; Bone Density; Lactobacillus reuteri; Anti-Bacterial Agents; Surveys and Questionnaires; Feces; Electric Impedance
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Ampicillin; Gentamicins
• Other Study ID Numbers: UPKLjubljana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO