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Effect of a Mixture of New Probiotic Strains in Preterm Infants

NCT03701906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-22

No results posted yet for this study

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.

Conditions

  • Premature Infant

Interventions

DIETARY_SUPPLEMENT

Lactobacillus PS11603 & Bifidobacterium PS10402

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

  • ProbiSearch SL

    lead INDUSTRY

Principal Investigators

  • Susana Manzano, PhD · ProbiSearch SL

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
5 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701906 on ClinicalTrials.gov