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

October 20, 2020 updated by: ProbiSearch SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeks
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.
Time Frame: 2 months
Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProbiSearch SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PRE/18.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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