Status:
COMPLETED
Safety of Bifidobacterium Breve PS1 for Infants
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Hospital General Universitario Gregorio Marañon
Gerencia de Atención Primaria, Madrid
Conditions:
Infant Development
Safety Issues
Eligibility:
All Genders
3-3 years
Phase:
NA
Brief Summary
The objective of this work was the characterization of the probiotic potential of Bifidobacterium breve PS1, a strain originally isolated from human milk. Subsequently, its safety and tolerance were e...
Detailed Description
Introduction Some perinatal circumstances, such as the mode of birth, can alter the composition of the infant gut microbiota. As an example, infants born by caesarean section are prone to gut dysbiosi...
Eligibility Criteria
Inclusion
- Healthy 3-months-old infants
- Formula-fed infants from birth
Exclusion
- History of mild or serious gastrointestinal disorders (history of chronic diarrhea or constipation, gastroesophageal reflux)
- Gastrointestinal surgery
- Cow's milk protein allergy
- Metabolic disorders (diabetes, lactose intolerance)
- Immune deficiency
- Antibiotic prescription three-weeks prior to inclusion
- Previous use of probiotic-containing formula.
Key Trial Info
Start Date :
December 12 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05973812
Start Date
December 12 2012
End Date
March 12 2015
Last Update
August 3 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Gregorio Marañón
Madrid, Spain, 28007
2
Universidad Complutense de Madrid
Madrid, Spain, 28040
3
Centro de Atención Primaria Silvano
Madrid, Spain, 28043