NCT04994834

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 0 Days – 2 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-03-30
• Completion: 2022-06-01
• First posted: 2021-08-06
• Last updated: 2022-07-12

Locations

1 site across 1 country: Denmark