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

NCT ID: NCT04987593

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-06-30

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.

Conditions

Infant Development; Gut Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

Four probiotic strains to be consumed once daily

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Pregnant women:

1. Enrolled at Aarhus University Hospital

2. Singleton pregnancy

3. Age above 18 years at informed consent

4. Aim to give birth vaginally

5. Aim to breastfeed

6. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Chr Hansen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Henning Pedersen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecology and Obstetrics, Aarhus University Hospital

Locations

Department of Gynaecology and Obstetrics

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

HND-IN-039

Identifier Type: -

Identifier Source: org_study_id