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

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994834
• Other study ID #: HND-IN-037
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2021
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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)

Related Conditions & MeSH terms

• Gut Microbiota

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Gynaecology and Obstetrics	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Chr Hansen	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Stool frequency and consistency	Infant stool frequency and consistency will be measured using Amsterdam Stool Chart.	42 days
Other	Reflux	Reflux will be measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)	42 days
Other	Breastmilk microbiome	Microbiome of the breastmilk to be assessed using sequencing to explore a potential microbiota of the breastmilk	Baseline, Day 14, Day 28
Other	Mothers vaginal microbiota	Characterization of mother's vaginal microbiota will be assessed using sequencing to examine the microbiota for similarities with the infant	Baseline
Primary	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	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
Secondary	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
Secondary	Adverse events (Safety)	Frequency and severity of adverse events	up to 6 weeks