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

Not Applicable

Completed

• Conditions: Preterms With Gestational Age Ranging From 30 to 35 Weeks
• Interventions: Dietary Supplement: Milk with probiotic and prebiotic activities; Dietary Supplement: Milk without probiotic and prebiotic activities

• Registration Number: NCT00711633
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2005-02
• Study Completion: 2007-06
• Status Verified: 2008-06
• Study First Submitted: 2008-07-04
• Study First Submitted QC: 2008-07-04
• Last Update Submitted: 2008-07-04
• Study First Posted: 2008-07-09
• Last Update Posted: 2008-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

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Exclusion Criteria

• Malformation or metabolic disease
• Newborns whose parents did not provide informed consent
• Contraindication to enteral feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Milk with probiotic and prebiotic activities	the fermented preterm formula (FPF)
2	Milk without probiotic and prebiotic activities	formula adapted for preterm infants (PF)

Primary Outcome Measures

Name	Time	Method
Follow-up of the number of colonized infants and the bacterial colonization levels	weekly until hospital discharge

Secondary Outcome Measures

Name	Time	Method
Clinical tolerance	weekly until hospital discharge
Levels of intestinal immune and inflammatory markers	weekly until hospital discharge

Trial Locations

Locations (1)

Neonatat unit, Saint Vincent de Paul Hospital; 🇫🇷 Paris, France