Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics

Chr. Hansen

Status: Completed

Conditions: Gut Microbiota

Treatments: Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04994834

HND-IN-037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Intervention

Experimental group

Description:

Probiotics

Treatment:

Dietary Supplement: Probiotics