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

Characterisation of the Gut Microbiota in Term Infants After Maternal Prenatal and Postnatal Supplementation of Probiotics - an Open Label Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Infant Development; Gut Microbiome
• Intervention / Treatment: Dietary supplement: Probiotics

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Department of Gynaecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Four probiotic strains to be consumed once daily	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of study product in maternal feces	Presence of at least one of the probiotic strains in maternal feces using PCR	28 days
Quantification of the microbiota in breastmilk	Characterization of breastmilk microbiota by and recovery of probiotic strains using PCR	28 days after birth
Quantification of the maternal vaginal microbiota	Characterization of the vaginal microbiota and recovery of probiotic strains using PCR	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant gastrointestinal problems	Infants gastrointestinal problems will be assessed using the Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems (ROME IV)	28 days
Infant stool frequency and consistency	Infants stool frequency and consistency will be assessed using Amsterdam Stool Chart	28 days
Infant Reflux	Reflux will be assessed using the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)	28 days
Adverse events	Any adverse events experienced by either mother or infant will be recorded during the entire study period	12 weeks

Collaborators and Investigators

• Sponsor: Chr Hansen
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Lars Henning Pedersen, MD, Department of Gynecology and Obstetrics, Aarhus university Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HND-IN-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD plan yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No