NCT02310425

Brief Summary

Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial infections and necrotizing enterocolitis (NEC) in the preterm infant. The effects of probiotics on growth and development in premature infants have been investigated poorly. Saccharomyces boulardii CNCM I-745 (S. boulardii) is a non-pathogenic probiotic yeast. Prophylactic supplementation of S. boulardii at a dose of 50 mg/kg twice a day appeared to bring preterm infants weight gain closer to that of intra-uterine growth rate, reduce feeding intolerance, and had no adverse effects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_3

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

March 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

4 months

First QC Date

November 27, 2014

Last Update Submit

December 4, 2014

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

  • weight

    weight gain (g/d)

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

Secondary Outcomes (4)

  • days of parenteral nutrition to full enteral nutrition

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

  • maximal enteral feed

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

  • fasting time

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

  • duration of hospitalisation

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

Other Outcomes (3)

  • linear

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

  • head circumference

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

  • chest circumference

    The study period ended at the 28th day after birth or when the infant was discharged from the hospital if earlier, but the total period of the study was at least 7 days.

Study Arms (2)

The study group

ACTIVE COMPARATOR

The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group.

Drug: S. boulardii

The control group

PLACEBO COMPARATOR

A prospective, Placebo Comparator,randomized case-controlled trial was conducted in infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g.

Drug: Placebo

Interventions

S. boulardiiDRUG

50 mg/kg twice daily

Also known as: probiotics
The study group
PlaceboDRUG

he control group (group C) did not receive S. boulardii (nor other probiotics)

Also known as: control group
The control group

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infant, Premature, Diseases

Interventions

ProbioticsControl Groups

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
A single blinded study on the effect of Saccharomyces boulardii CNCM I-745 on growth and development in preterm infants

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 8, 2014

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12