Effect of Probiotics on Infant's Fecal Microbiota Composition

AB Biotics, SA120 enrolled

Overview

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.

Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

120

Conditions

Microbial Colonization

Interventions

Food Supplement 1DIETARY_SUPPLEMENT

Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day

Food Supplement 2DIETARY_SUPPLEMENT

Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day

PlaceboDIETARY_SUPPLEMENT

5 drops/day for 3 months of sunflower oil

Eligibility

Sex: ALLMin age: 1 DayMax age: 90 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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) * APGAR test score for birth normal at 1' and 5' of 7-10 * Whose parents accept the follow-up of the study procedures and sign the informed consent Exclusion Criteria: * 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 * Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition * Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant * TORCH complex infections * Every other diseases related with the immune system * Parents who can not accomplish the follow-up of the study (medical criterium)

Locations (2)

Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco

Alcaldía Coyoacán, Puebla, Mexico

NOT_YET_RECRUITING

Clínica Viamed Montecanal

Zaragoza, Aragon, Spain

RECRUITING

Outcomes

Primary Outcomes

Change of Bifidobacterium longum and Pediococcus pentosaceus in feces

Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR

Time frame: day 0, month 3