NCT06501404

Brief Summary

The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
583

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2015

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

5 days

First QC Date

June 19, 2024

Last Update Submit

July 12, 2024

Conditions

Premature InfantsNecrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of necrotizing enterocolitis and all-cause mortality

    The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.

    From birth until three months

Secondary Outcomes (8)

  • Intestinal colonization by administered strains

    From birth until three months

  • Incidence of Late Onset Sepsis

    From birth until three months

  • Time to complete enteral nutrition

    From birth until three months

  • Days of Central Vascular Catheter

    From birth until three months

  • Length of hospital stay

    From birth until three months

  • +3 more secondary outcomes

Study Arms (2)

High dose of probiotic mixture

EXPERIMENTAL

A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains

Dietary Supplement: High dose group

Low dose of probiotic mixture

EXPERIMENTAL

A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains

Dietary Supplement: Low dose group

Interventions

High dose groupDIETARY_SUPPLEMENT

A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains

High dose of probiotic mixture
Low dose groupDIETARY_SUPPLEMENT

A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains

Low dose of probiotic mixture

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
  • Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.

You may not qualify if:

  • Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
  • Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
  • Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen de las Nieves

Granada, 18012, Spain

Location

MeSH Terms

Conditions

Premature BirthEnterocolitis, Necrotizing

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Neonatolgy Division. University Hospital Virgen de las Nieves

Study Record Dates

First Submitted

June 19, 2024

First Posted

July 15, 2024

Study Start

January 10, 2015

Primary Completion

January 15, 2015

Study Completion

March 20, 2020

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)