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

Study Overview
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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.

Official Title
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Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers

Conditions
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Preterms With Gestational Age Ranging From 30 to 35 Weeks

Intervention / Treatment
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* Dietary Supplement: Milk with probiotic and prebiotic activities
* Dietary Supplement: Milk without probiotic and prebiotic activities


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 15 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>the fermented preterm formula (FPF) | Dietary Supplement: Milk with probiotic and prebiotic activities<br>* Comparison of two different formula for preterm infants<br>|
| Placebo Comparator: 2<br>formula adapted for preterm infants (PF) | Dietary Supplement: Milk without probiotic and prebiotic activities<br>* Comparison of formula for preterm infants<br>* Other names: Comparison of formula for preterm infants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up of the number of colonized infants and the bacterial colonization levels |  | weekly until hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical tolerance |  | weekly until hospital discharge | 
| Levels of intestinal immune and inflammatory markers |  | weekly until hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature birth,, infant,, infant formula,, bacterial colonization,, Bifidobacterium,, calprotectin