Clinical trial NCT04994834: Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics
Official title: Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
Collaborators: name: Aarhus University Hospital
First posted: 2021-08-06
Enrollment: 22
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.

Detailed description: The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product.

During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily.

Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. 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: Infants to be enrolled at birth.

Inclusion Criteria for Infants (study subjects)

* Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks
* Birthweight more than 2500 g
* No exposure to oral or intravenous antibiotics
* No complications that need medical interventions (e.g. respiratory distress symptoms or infections)
* Both legal guardians provided voluntary written informed consent on behalf of the infant

Pregnant women:

* Women age above 18 years at informed consent
* Singleton pregnancy
* Uncomplicated pregnancy
* No use of medication
* Aim to give birth vaginally and breastfeed
* No use of probiotics during the last month before estimated birth and until six weeks postpartum
* Provided voluntary written informed consent

Exclusion criteria for Infants (study subjects)

• Admission to the neonatal intensive care unit (NICU)

Primary outcomes:
measure: Recovery of the investigational product in the infant feces
timeFrame: 28 days after birth
Secondary outcomes:
measure: Total fecal Bifidobacterium in infant fecal samples
timeFrame: Baseline, Day14, Day 28
measure: Characterization of the infant intestinal microbiota after 4 weeks supplementation
timeFrame: Baseline, Day 14, Day 28
measure: Adverse events (Safety)
timeFrame: up to 6 weeks
Other outcomes:
measure: Mothers fecal microbiota
timeFrame: Baseline
measure: Infant Gastrointestinal Problems
timeFrame: 42 days
measure: Stool frequency and consistency
timeFrame: 42 days
measure: Reflux
timeFrame: 42 days
measure: Breastmilk microbiome
timeFrame: Baseline, Day 14, Day 28
measure: Mothers vaginal microbiota
timeFrame: Baseline
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, Professor
role: PRINCIPAL_INVESTIGATOR
References: