SBP: A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: The study group The study group received S. boulardii supplementation, 50 mg/kg twice daily, compared to no intervention in the control group. |
Drug: S. boulardii
50 mg/kg twice daily
Other Names:
|
| Placebo Comparator: 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. |
Drug: Placebo
he control group (group C) did not receive S. boulardii (nor other probiotics)
Other Names:
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Outcome Measures
Primary Outcome Measures
- weight [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.]
weight gain (g/d)
Secondary Outcome Measures
- 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.]
count the days of parenteral nutrition to full enteral nutrition
- 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.]
measure maximal enteral feed (ml/day)
- 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.]
count fasting time (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.]
count the duration of hospitalisation (days)
Other Outcome Measures
- 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.]
linear growth (cm/week)
- 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.]
head circumference growth (cm/week)
- 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.]
chest circumference growth (cm/week).
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lingfen Xu, MD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMU1