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

NCT ID: NCT04994834

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-06-01

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.

Conditions

Gut Microbiota

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

Probiotics

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotics

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• Admission to the neonatal intensive care unit (NICU)

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Chr Hansen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Henning Pedersen, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecology and Obstetrics, Aarhus University Hospital

Locations

Department of Gynaecology and Obstetrics

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

HND-IN-037

Identifier Type: -

Identifier Source: org_study_id