Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics

Study Overview
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Brief Summary
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A monocenter, open label pilot study in pregnant women and their offspring with at least four weeks prenatal and four weeks postnatal maternal intervention with a study product consisting of four different food constituents. The study will investigate the effect of maternal supplementation with the food constituents on the recovery of the constituents in the maternal and infant feces, the microbiota in both mother and infant and potential transmission routes from mother to infant.

Detailed Description
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Pregnant women will be recruited at the ordinary midwife visit in gestational week 28. The intervention will begin in gestational week 33+0 to ensure at least four weeks prenatal intervention before expected birth. The study will be conducted in four phases. First phase is the run-in phase. The second phase is the prenatal intervention period from gestational week 33+0 until birth. Third phase is the postnatal intervention period, from birth until four weeks postnatal. The last phase is a two weeks follow-up period without any intake of the investigational product. Infant stool samples, as well as maternal breast milk samples, stool and urine samples and samples from vagina will be collected on multiple occasions during the study. 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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Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study

Conditions
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Infant Development, Gut Microbiome

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Pregnant women: Enrolled at Aarhus University Hospital Singleton pregnancy Age above 18 years at informed consent Aim to give birth vaginally Aim to breastfeed No use of probiotics (contained in dietary supplements/ food) after written consent. Infants: 1. Gestational age between 37-42 weeks Exclusion Criteria: Pregnant women • Use of immunosuppressant drugs. Infants: • None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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>Four probiotic strains to be consumed once daily | Dietary Supplement: Probiotics<br>* Once a day daily intake of probiotics, at least for 28 consecutive days before giving birth and for at least 28 consecutive days after giving birth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of study product in infant feces | Presence of at least one of the probiotic strains in infant feces using PCR | 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of study product in maternal feces | Presence of at least one of the probiotic strains in maternal feces using PCR | 28 days | 
| Quantification of the microbiota in breastmilk | Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR | 28 days after birth | 
| Quantification of the maternal vaginal microbiota | Characterization of the vaginal microbiota and recovery of probiotic strains using PCR | 28 days |