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

NCT ID: NCT02310425

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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).

Conditions

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Infant, Premature, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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The study group

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

Group Type ACTIVE_COMPARATOR

S. boulardii

Intervention Type DRUG

50 mg/kg twice daily

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

he control group (group C) did not receive S. boulardii (nor other probiotics)

Interventions

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S. boulardii

50 mg/kg twice daily

Intervention Type DRUG

Placebo

he control group (group C) did not receive S. boulardii (nor other probiotics)

Intervention Type DRUG

Other Intervention Names

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probiotics control group

Eligibility Criteria

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Inclusion 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.
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lingfen Xu, MD

OTHER

Sponsor Role lead

Responsible Party

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Lingfen Xu, MD

A single blinded study on the effect of Saccharomyces boulardii CNCM I-745 on growth and development in preterm infants

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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CMU1

Identifier Type: -

Identifier Source: org_study_id