Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastrointestinal Diseases, Colic

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM 17938
* Dietary Supplement: Placebo
* Drug: ampicillin and gentamicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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<br> <br> * Other names: BioGaia;Drug: ampicillin and gentamicin<br> <br> |
| Placebo Comparator: Placebo group<br>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<br> <br> Drug: ampicillin and gentamicin<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Anti-Bacterial Agents, Infant, Newborn, Gastrointestinal Microbiome, Colic, Gastrointestinal Diseases, Body Composition, Bone Density, Randomized Controlled Trial, Lactobacillus reuteri, Pediatrics, Feces, ultrasonography, High-Throughput Nucleotide Sequencing, Electric Impedance, Surveys and Questionnaires