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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Lingfen Xu, MD

Current Primary Outcome: weight [ 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. ]

weight gain (g/d)


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: China Medical University, China

Dates:
Date Received: November 27, 2014
Date Started: March 2013
Date Completion:
Last Updated: December 4, 2014
Last Verified: December 2014