Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics

Study Overview
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Brief Summary
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A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.

Detailed Description
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The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product. During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily. Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.

Official Title
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Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study

Conditions
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Gut Microbiota

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Infants to be enrolled at birth. Inclusion Criteria for Infants (study subjects) Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks Birthweight more than 2500 g No exposure to oral or intravenous antibiotics No complications that need medical interventions (e.g. respiratory distress symptoms or infections) Both legal guardians provided voluntary written informed consent on behalf of the infant Pregnant women: Women age above 18 years at informed consent Singleton pregnancy Uncomplicated pregnancy No use of medication Aim to give birth vaginally and breastfeed No use of probiotics during the last month before estimated birth and until six weeks postpartum Provided voluntary written informed consent Exclusion criteria for Infants (study subjects) • Admission to the neonatal intensive care unit (NICU)

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Probiotics | Dietary Supplement: Probiotics<br>* Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of the investigational product in the infant feces | Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR | 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fecal Bifidobacterium in infant fecal samples | Total fecal Bifidobacterium in infant fecal samples after 4 weeks supplementation Quantification of total Bifidobacterium will be determined by PCR. | Baseline, Day14, Day 28 | 
| Characterization of the infant intestinal microbiota after 4 weeks supplementation | Characterization of the infant intestinal microbiota after 4 weeks supplementation of the investigational product using sequencing | Baseline, Day 14, Day 28 | 
| Adverse events (Safety) | Frequency and severity of adverse events | up to 6 weeks |