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
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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