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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)

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ClinicalTrials.gov Identifier: NCT02310425
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Lingfen Xu, MD, China Medical University, China

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
Infant, Premature, Diseases Drug: S. boulardii Drug: Placebo 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : January 2014

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 Name: probiotics

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 Name: control group




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)


Other Outcome Measures:
  1. linear [ 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. ]
    linear growth (cm/week)

  2. head circumference [ 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. ]
    head circumference growth (cm/week)

  3. chest circumference [ 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. ]
    chest circumference growth (cm/week).



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Layout table for additonal information
Responsible Party: Lingfen Xu, MD, A single blinded study on the effect of Saccharomyces boulardii CNCM I-745 on growth and development in preterm infants, China Medical University, China
ClinicalTrials.gov Identifier: NCT02310425    
Other Study ID Numbers: CMU1
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Infant, Premature, Diseases
Infant, Newborn, Diseases