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

NCT04987593 | Completed

• 1 other identifier: HND-IN-039
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Recovery of study product in maternal feces

  28 days

• Quantification of the microbiota in breastmilk

  28 days after birth

• Quantification of the maternal vaginal microbiota

  28 days

Other Outcomes (4)

• Infant gastrointestinal problems

  28 days

• Infant stool frequency and consistency

  28 days

• Infant Reflux

  28 days

Study Arms (1)

Intervention

EXPERIMENTAL

Four probiotic strains to be consumed once daily

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Gestational age between 37-42 weeks

You may not qualify if:

• Pregnant women • Use of immunosuppressant drugs.
• Infants:
• None

Sponsors & Collaborators

• Chr Hansen: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Gynaecology and Obstetrics

Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lars Henning Pedersen, MD

  Department of Gynecology and Obstetrics, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: August 3, 2021
• Study Start: August 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: July 12, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)