Effect of a Mixture of New Probiotic Strains in Preterm Infants (PREBIOMA)

ProbiSearch

Status: Completed

Conditions: Premature Infant

Treatments: Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03701906

PRE/18.02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 1 minute to 5 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Lactobacillus PS11603 & Bifidobacterium PS10402

Active Comparator group

Description:

A mixture of 1\*10E9 colony forming unit (CFU) of Lactobacillus PS11603 and 1\*10E8 CFU of Bifidobacterium PS10402 in 1 vial will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age.

Treatment:

Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402

Placebo

Active Comparator group

Description:

1 vial of Placebo will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age.

Treatment:

Dietary Supplement: Placebo