Effect of Probiotics on Infant's Fecal Microbiota Composition (BABYCARE)

AB Biotics

Status: Enrolling

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Food Supplement 1; Dietary Supplement: Placebo; Dietary Supplement: Food Supplement 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05524649

AB-BABYCARE-21

Details and patient eligibility

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 90 days old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.

Treatment:

Dietary Supplement: Food Supplement 1

Experimental 2

Experimental group

Description:

Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority.

Treatment:

Dietary Supplement: Food Supplement 2

Placebo

Placebo Comparator group

Description:

Sunflower oil

Treatment:

Dietary Supplement: Placebo