Clinical trial NCT00711633: Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants
Official title: Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterms With Gestational Age Ranging From 30 to 35 Weeks
Keywords: Premature birth,
infant,
infant formula,
bacterial colonization,
Bifidobacterium,
calprotectin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Blédina SA, Villefranche sur Saône, France
First posted: 2008-07-09
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Follow-up of the number of colonized infants and the bacterial colonization levels
timeFrame: weekly until hospital discharge
Secondary outcomes:
measure: Clinical tolerance
timeFrame: weekly until hospital discharge
measure: Levels of intestinal immune and inflammatory markers
timeFrame: weekly until hospital discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: Neonatat unit, Saint Vincent de Paul Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence Campeotto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.