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

NCT04994834 | Completed

• 1 other identifier: HND-IN-037
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total fecal Bifidobacterium in infant fecal samples

  Baseline, Day14, Day 28

• Characterization of the infant intestinal microbiota after 4 weeks supplementation

  Baseline, Day 14, Day 28

• Adverse events (Safety)

  up to 6 weeks

Other Outcomes (6)

• Mothers fecal microbiota

  Baseline

• Infant Gastrointestinal Problems

  42 days

• Stool frequency and consistency

  42 days

Study Arms (1)

Intervention

EXPERIMENTAL

Probiotics

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth

Intervention

Eligibility Criteria

• Age: 0 Days - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Admission to the neonatal intensive care unit (NICU)

Sponsors & Collaborators

• Chr Hansen: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Gynaecology and Obstetrics

Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lars Henning Pedersen, Professor

  Department of Gynecology and Obstetrics, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 6, 2021
• Study Start: July 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 1, 2022
• Last Updated: July 12, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)