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
About this trial
This is an interventional treatment trial for Infant, Premature, Diseases
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.
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
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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