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

Not Applicable

Completed

• Conditions: Infant Development; Gut Microbiome
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT04987593
• Lead Sponsor: Chr Hansen

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-29
• Status Verified: 2021-08
• Study Start: 2021-08-01
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Primary Completion: 2022-03-31
• Study Completion: 2022-06-30
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Pregnant women • Use of immunosuppressant drugs.

Infants:

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Probiotics	Four probiotic strains to be consumed once daily

Primary Outcome Measures

Name	Time	Method
Recovery of study product in infant feces	28 days after birth	Presence of at least one of the probiotic strains in infant feces using PCR

Secondary Outcome Measures

Name	Time	Method
Recovery of study product in maternal feces	28 days	Presence of at least one of the probiotic strains in maternal feces using PCR
Quantification of the microbiota in breastmilk	28 days after birth	Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR
Quantification of the maternal vaginal microbiota	28 days	Characterization of the vaginal microbiota and recovery of probiotic strains using PCR

Trial Locations

Locations (1)

Department of Gynaecology and Obstetrics; 🇩🇰 Aarhus, Denmark