Status:
COMPLETED
Safety and Tolerance Study of Three Probiotic Strains in Infants
Lead Sponsor:
ProbiSearch SL
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
Body Weight
Body Height
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy infants. Participants are divided at random and unknown to the researchers, in four groups, three of which rece...
Detailed Description
Subjects' parents or legal tutors will be contacted for voluntary participation and a written informed consent will be obtained. The study visits will take place either in the hospital or primary hea...
Eligibility Criteria
Inclusion
- Healthy term infants between 3-12 months old
- Written informed consent from at least one parent or the legal tutor.
Exclusion
- Short bowel syndrome or any GI surgery.
- Impaired intestinal epithelial barrier (e.g. diarrheal illness, intestinal inflammation).
- Metabolic disorders (diabetes, lactose intolerance).
- Immunodeficiency.
- Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infectious endocarditis, cardiac malformation, rheumatic fever).
- Surgery within one month prior to inclusion (Visit 1/ week 0).
- Antibiotic prescription 1 week before inclusion (Visit 1/ week 0) and during run-in period (Visit 2/ week 2).
- Investigator's uncertainty about the willingness or ability of the infant's parents to comply with the protocol requirements.
- Participation in any other clinical trial within two weeks prior to entry into the study.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT02215304
Start Date
June 1 2014
End Date
July 1 2015
Last Update
December 14 2016
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046