Effect of a Mixture of New Probiotic Strains in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.

Conditions
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Premature Infant

Intervention / Treatment
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* Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus PS11603 & Bifidobacterium PS10402<br>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. | Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402<br>* 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.<br>* Other names: Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeks;|
| Active Comparator: Placebo<br>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. | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months |