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A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants (SBP)

Primary Purpose

Infant, Premature, Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
S. boulardii
Placebo
Sponsored by
Lingfen Xu, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases

Eligibility Criteria

undefined - 28 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The inclusion criteria were hospital born infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g.

Exclusion Criteria:

  • Exclusion criteria were severe neonatal pathology such as birth complications, GI malformations, chromosomal abnormalities, known immunodeficiency, hydrops foetalis, a central venous catheter and the use of antifungal drugs or probiotics.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    The study group

    The control group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    weight
    weight gain (g/d)

    Secondary Outcome Measures

    days of parenteral nutrition to full enteral nutrition
    count the days of parenteral nutrition to full enteral nutrition
    maximal enteral feed
    measure maximal enteral feed (ml/day)
    fasting time
    count fasting time (days)
    duration of hospitalisation
    count the duration of hospitalisation (days)

    Full Information

    First Posted
    November 27, 2014
    Last Updated
    December 4, 2014
    Sponsor
    Lingfen Xu, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02310425
    Brief Title
    A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
    Acronym
    SBP
    Official Title
    A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lingfen Xu, MD

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    The objective of this study is to evaluate if feeding supplemented with S. boulardii can improve growth and clinical outcomes in preterm and low birth weight infants. A prospective, 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. The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group. The primary outcomes were short term growth parameters including weight gain, linear growth, head and chest circumference, and secondary outcomes were clinical outcomes, feeding intolerance and complications. A total of 125 infants were enrolled in the study, 63 in the treatment and 62 in the control group. S. boulardii was administered for the first time at 2.63 days after birth (1 day to 6 days, 46 within 3 days, only 5 between 4 and 6 days).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infant, Premature, Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The study group
    Arm Type
    Active Comparator
    Arm Description
    The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group.
    Arm Title
    The control group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    S. boulardii
    Other Intervention Name(s)
    probiotics
    Intervention Description
    50 mg/kg twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    control group
    Intervention Description
    he control group (group C) did not receive S. boulardii (nor other probiotics)
    Primary Outcome Measure Information:
    Title
    weight
    Description
    weight gain (g/d)
    Time Frame
    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 Outcome Measure Information:
    Title
    days of parenteral nutrition to full enteral nutrition
    Description
    count the days of parenteral nutrition to full enteral nutrition
    Time Frame
    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.
    Title
    maximal enteral feed
    Description
    measure maximal enteral feed (ml/day)
    Time Frame
    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.
    Title
    fasting time
    Description
    count fasting time (days)
    Time Frame
    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.
    Title
    duration of hospitalisation
    Description
    count the duration of hospitalisation (days)
    Time Frame
    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 Pre-specified Outcome Measures:
    Title
    linear
    Description
    linear growth (cm/week)
    Time Frame
    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.
    Title
    head circumference
    Description
    head circumference growth (cm/week)
    Time Frame
    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.
    Title
    chest circumference
    Description
    chest circumference growth (cm/week).
    Time Frame
    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.

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria were hospital born infants with a gestational age of 30 to 37 weeks and a birth weight between 1500 to 2500 g. Exclusion Criteria: Exclusion criteria were severe neonatal pathology such as birth complications, GI malformations, chromosomal abnormalities, known immunodeficiency, hydrops foetalis, a central venous catheter and the use of antifungal drugs or probiotics.

    12. IPD Sharing Statement

    Learn more about this trial

    A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants

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