Actively Recruiting
Effect of Probiotics on Infant's Fecal Microbiota Composition
Led by AB Biotics, SA · Updated on 2025-02-11
120
Participants Needed
2
Research Sites
187 weeks
Total Duration
On this page
Sponsors
A
AB Biotics, SA
Lead Sponsor
M
Ministry of Science and Innovation, Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Probiotics on Infant's Fecal Microbiota Composition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants
- Age between 1 and 90 days
- Gestational age between 37 and 42 weeks
- Appropriate birth weight for gestational age (between P10 and P90)
- APGAR test score of 7-10 at 1 and 5 minutes after birth
- Parents willing to follow study procedures and provide signed informed consent
You will not qualify if you...
- Participation in another clinical study
- Infants fed with formula or supplements containing probiotics within 4 weeks prior to study start
- Infants who have taken antibiotics within 4 weeks prior to study start
- Infants with cow's milk protein allergy, lactose intolerance, or other digestive diseases
- Maternal history of neurologic disorders, metabolic diseases, type 1 diabetes, chronic diseases, or malnutrition during pregnancy
- Acute congenital or acquired diseases affecting growth or feeding
- TORCH complex infections
- Any disease related to the immune system
- Parents unable to comply with study follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco
Alcaldía Coyoacán, Puebla, Mexico, 04530
Not Yet Recruiting
2
Clínica Viamed Montecanal
Zaragoza, Aragon, Spain, 50012
Actively Recruiting
Research Team
G
Gerardo Rodríguez Martínez, MD
CONTACT
M
Meritxell Aguilo Garcia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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