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

Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Gut Microbiota
• Intervention / Treatment: Dietary supplement: Probiotics

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 Type: Interventional
• Enrollment (Actual): 22
• 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: 1 second to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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; Probiotics	Dietary supplement: Probiotics; Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mothers fecal microbiota	Characterization of mother's microbiota from fecal samples will be assessed using sequencing to examine the microbiota for similarities with the infant	Baseline
Infant Gastrointestinal Problems	Infant Gastrointestinal Problems will be measured using ROME IV Diagnostic Questionnaires for Pediatric Functional Gastrointestinal Disorders for Neonates and Toddlers: Parent-Report Form for Neonates Section A - Infant Gastrointestinal Problems	42 days
Stool frequency and consistency	Infant stool frequency and consistency will be measured using Amsterdam Stool Chart.	42 days
Reflux	Reflux will be measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)	42 days
Breastmilk microbiome	Microbiome of the breastmilk to be assessed using sequencing to explore a potential microbiota of the breastmilk	Baseline, Day 14, Day 28
Mothers vaginal microbiota	Characterization of mother's vaginal microbiota will be assessed using sequencing to examine the microbiota for similarities with the infant	Baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 6, 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-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: To share IPD not decided 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