Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

Gastrointestinal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865564
• Other study ID #: UPKLjubljana
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2020

Study information

• Verified date: January 2024
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Days

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• Lactobacillus reuteri DSM 17938

• Placebo

Drug:
• ampicillin and gentamicin

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional gastrointestinal dysfunction	Questionnaire [/]	At 6 months of age
Primary	Composition of gut microbiota in infants - 1	[colony-forming units/ml; /]	At 6 weeks after intervention
Primary	Infants crying duration time	Questionnaire [/]	At 6 months of age
Primary	Composition of gut microbiota in infants - 2	[colony-forming units/ml; /]	At one year of age
Secondary	Infant weight - 1	[kg]; to calculate body mass index	At 6 months of age
Secondary	Bone mineral density in infants - 1	Z-score [/]	At 6 months of age
Secondary	Infant height - 1	[m]; to calculate body mass index	At 6 months of age
Secondary	Infant weight - 2	[kg]; to calculate body mass index	At 12 months of age
Secondary	Bone mineral density in infants - 2	Z-score [/]	At 12 months of age
Secondary	Infant height - 2	[m]; to calculate body mass index	At 12 months of age
Secondary	Body composition of infants - 1		At 6 months of age
Secondary	Body composition of infants - 2		At 12 months of age