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Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants

NCT ID: NCT00711633

Last Updated: 2008-07-09

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

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-06-30

Brief Summary

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The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.The aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.

Detailed Description

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This prospective, randomized, double-blind, controlled study evaluated the safety and effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants. Preterm infants with a gestational age (GA) ranging from 30 to 35 weeks and whose mother chose formula feeding were enrolled during their first three days of life. Both parents provided informed written consent. Infants were randomly assigned to receive either the fermented preterm formula (FPF) or, as a control, a formula adapted for preterm infants (PF). The PF was formulated to meet the nutritional needs of preterm infants. The FPF was identical, except for a manufacturing process including a fermentation step with two probiotic strains, Bifidobacterium breve C50 and Streptococcus thermophilus 065, inactivated by heat at the end of the manufacturing process. This process conferred a probiotic/prebiotic activity.For each neonate, background information about the pregnancy and neonatal parameters were collected. Anthropometric parameters (weight, height, head circumference); gastrointestinal tolerance parameters (abdominal distension, gastric residuals, rectal bleeding, NEC); drug administration; and intake of formula and mother's milk were recorded twice a week until discharge. Stools were collected twice a week from diapers for microbiological analysis and measurement of fecal inflammatory markers. All samples were immediately stored at -80°C.

Conditions

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Preterms With Gestational Age Ranging From 30 to 35 Weeks

Keywords

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Premature birth, infant, infant formula, bacterial colonization, Bifidobacterium, calprotectin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

the fermented preterm formula (FPF)

Group Type EXPERIMENTAL

Milk with probiotic and prebiotic activities

Intervention Type DIETARY_SUPPLEMENT

Comparison of two different formula for preterm infants

2

formula adapted for preterm infants (PF)

Group Type PLACEBO_COMPARATOR

Milk without probiotic and prebiotic activities

Intervention Type DIETARY_SUPPLEMENT

Comparison of formula for preterm infants

Interventions

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Milk with probiotic and prebiotic activities

Comparison of two different formula for preterm infants

Intervention Type DIETARY_SUPPLEMENT

Milk without probiotic and prebiotic activities

Comparison of formula for preterm infants

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Comparison of formula for preterm infants

Eligibility Criteria

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Inclusion Criteria

* Preterms with gestational age ranging from 30 to 35 weeks
* Eutrophic
* Formula feeding

Exclusion Criteria

* Malformation or metabolic disease
* Newborns whose parents did not provide informed consent
* Contraindication to enteral feeding
Minimum Eligible Age

1 Day

Maximum Eligible Age

15 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blédina SA, Villefranche sur Saône, France

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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URC Paris Centre

Principal Investigators

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Florence Campeotto, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Neonatat unit, Saint Vincent de Paul Hospital

Paris, , France

Site Status

Countries

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France

References

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Campeotto F, Waligora-Dupriet AJ, Doucet-Populaire F, Kalach N, Dupont C, Butel MJ. [Establishment of the intestinal microflora in neonates]. Gastroenterol Clin Biol. 2007 May;31(5):533-42. doi: 10.1016/s0399-8320(07)89424-3. French.

Reference Type BACKGROUND
PMID: 17541346 (View on PubMed)

Other Identifiers

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1977/06-05-02

Identifier Type: -

Identifier Source: org_study_id