Effect of a Mixture of New Probiotic Strains in Preterm Infants

N/ACompletedNCT03701906

ProbiSearch SL30 enrolled

Overview

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation. The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.

An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation. The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Premature Infant

Interventions

Lactobacillus PS11603 & Bifidobacterium PS10402DIETARY_SUPPLEMENT

Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1\*10E9 CFU of L.salivarius PS11603 and 1\*10E8 CFU of B.longum PS10402.

PlaceboDIETARY_SUPPLEMENT

8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement.

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 5 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation. * Written informed consent signed by the parent or legal guardian. * Tolerate enteral feeding, at least 10mL / kg / day. * Postnatal age ≤ 5 days Exclusion Criteria: * Child with malformations * With short bowel syndrome or any surgery in the gastrointestinal tract * With defect in the intestinal epithelial barrier

Locations (1)

Hospital Universitario La Paz

Madrid, Spain

Outcomes

Primary Outcomes

Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.

Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants

Time frame: 2 months

Data from ClinicalTrials.gov

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