Effect of Probiotics on Infant's Fecal Microbiota Composition
ConditionMicrobial Colonization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-90
SponsorAB Biotics, SA
About this trial
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Eligibility criteria
Qualifiers
Healthy infants
Age between 1 and 90 days
Gestational age between 37 and 42 weeks
Appropiate birth weight for gestational age (between P10 and P90)
Disqualifiers
Infants participating in other clinical study
Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
Infants who have taken antibiotics 4 weeks prior the start study
Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
Trial design
Treatments tested in this trial
- Food Supplement 1
- Food Supplement 2
- Placebo
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
AB Biotics, SA
Lead sponsor
Ministry of Science and Innovation, Spain
Collaborator
Source ClinicalTrials.gov