NCT03701906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 8, 2018

Last Update Submit

October 20, 2020

Conditions

Premature Infant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lactobacillus PS11603 & Bifidobacterium PS10402

ACTIVE COMPARATOR

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

Placebo

ACTIVE COMPARATOR

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

Interventions

Lactobacillus PS11603 & Bifidobacterium PS10402DIETARY_SUPPLEMENT

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.

Also known as: Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeks
Lactobacillus PS11603 & Bifidobacterium PS10402
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age1 Minute - 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Child with malformations
  • With short bowel syndrome or any surgery in the gastrointestinal tract
  • With defect in the intestinal epithelial barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

  • Moreno-Sanz B, Montes MT, Manzano S, Espinosa-Martos I, Cardenas N, Esteban S, Cruz M, Jimenez E, de Pipaon MS. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):e153-e159. doi: 10.1097/MPG.0000000000003427. Epub 2022 Feb 25.

    PMID: 35221319DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Susana Manzano, PhD

    ProbiSearch SL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

October 22, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

ES(1)