Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gut Microbiota
- Sponsor
- Chr Hansen
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Recovery of the investigational product in the infant feces
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recovery of the investigational product in the infant feces
Time Frame: 28 days after birth
Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR
Secondary Outcomes
- 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)