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

Not Applicable

Completed

• Conditions: Gut Microbiota
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT04994834
• Lead Sponsor: Chr Hansen

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.

Study Timeline

• Study First Submitted: 2021-06-30
• Study Start: 2021-07-15
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-06
• Primary Completion: 2022-03-30
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Probiotics	Probiotics

Primary Outcome Measures

Name	Time	Method
Recovery of the investigational product in the infant feces	28 days after birth	Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR

Secondary Outcome Measures

Name	Time	Method
Total fecal Bifidobacterium in infant fecal samples	Baseline, Day14, Day 28	Total fecal Bifidobacterium in infant fecal samples after 4 weeks supplementation Quantification of total Bifidobacterium will be determined by PCR.
Characterization of the infant intestinal microbiota after 4 weeks supplementation	Baseline, Day 14, Day 28	Characterization of the infant intestinal microbiota after 4 weeks supplementation of the investigational product using sequencing
Adverse events (Safety)	up to 6 weeks	Frequency and severity of adverse events

Trial Locations

Locations (1)

Department of Gynaecology and Obstetrics; 🇩🇰 Aarhus, Denmark