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

NCT04987593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-07-12

No results posted yet for this study

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.

Conditions

  • Infant Development
  • Gut Microbiome

Interventions

DIETARY_SUPPLEMENT

Probiotics

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Chr Hansen

    lead INDUSTRY

Principal Investigators

  • Lars Henning Pedersen, MD · Department of Gynecology and Obstetrics, Aarhus University Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-03-31
Completion
2022-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987593 on ClinicalTrials.gov