Clinical trial NCT04987593: Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics
Official title: Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Gut Microbiome
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
Collaborators: name: Aarhus University Hospital
First posted: 2021-08-03
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Recovery of study product in infant feces
timeFrame: 28 days after birth
Secondary outcomes:
measure: Recovery of study product in maternal feces
timeFrame: 28 days
measure: Quantification of the microbiota in breastmilk
timeFrame: 28 days after birth
measure: Quantification of the maternal vaginal microbiota
timeFrame: 28 days
Other outcomes:
measure: Infant gastrointestinal problems
timeFrame: 28 days
measure: Infant stool frequency and consistency
timeFrame: 28 days
measure: Infant Reflux
timeFrame: 28 days
measure: Adverse events
timeFrame: 12 weeks
Locations:
city: Aarhus
country: Denmark
facility: Department of Gynaecology and Obstetrics
Study officials:
affiliation: Department of Gynecology and Obstetrics, Aarhus University Hospital
name: Lars Henning Pedersen, MD
role: PRINCIPAL_INVESTIGATOR
References: