Effect of a Mixture of New Probiotic Strains in Preterm Infants

Not Applicable

Completed

• Conditions: Premature Infant
• Interventions: Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402; Dietary Supplement: Placebo

• Registration Number: NCT03701906
• Lead Sponsor: ProbiSearch SL

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Study Start: 2018-10-22
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus PS11603 & Bifidobacterium PS10402	Lactobacillus PS11603 & Bifidobacterium PS10402	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.	2 months	Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain