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NCT03701906 Clinical Trial

Effect of a Mixture of New Probiotic Strains in Preterm Infants

Premature Infant Clinical Trial

— PREBIOMA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03701906
Other study ID # PRE/18.02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2018
Est. completion date December 31, 2019

Study information
Verified date October 2020
Source ProbiSearch SL
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 5 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Spain Hospital Universitario La Paz Madrid

Sponsors (1)
Lead Sponsor Collaborator
ProbiSearch SL

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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