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

This study has been completed.
Sponsor:
Collaborator:
Blédina SA, Villefranche sur Saône, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00711633
First received: July 4, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

July 4, 2008
July 4, 2008
December 2002
February 2005   (final data collection date for primary outcome measure)
Follow-up of the number of colonized infants and the bacterial colonization levels [ Time Frame: weekly until hospital discharge ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Clinical tolerance [ Time Frame: weekly until hospital discharge ] [ Designated as safety issue: Yes ]
  • Levels of intestinal immune and inflammatory markers [ Time Frame: weekly until hospital discharge ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants
Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Preterms With Gestational Age Ranging From 30 to 35 Weeks
  • Dietary Supplement: Milk with probiotic and prebiotic activities
    Comparison of two different formula for preterm infants
    Other Name: Milk with probiotic and prebiotic activities
  • Dietary Supplement: Milk without probiotic and prebiotic activities
    Comparison of formula for preterm infants
    Other Name: Comparison of formula for preterm infants
  • Experimental: 1
    the fermented preterm formula (FPF)
    Intervention: Dietary Supplement: Milk with probiotic and prebiotic activities
  • Placebo Comparator: 2
    formula adapted for preterm infants (PF)
    Intervention: Dietary Supplement: Milk without probiotic and prebiotic activities
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. Review. French.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
June 2007
February 2005   (final data collection date for primary outcome measure)

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
Both
up to 15 Days
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00711633
1977/06-05-02
No
Serreau, URC Paris Centre
Assistance Publique - Hôpitaux de Paris
Blédina SA, Villefranche sur Saône, France
Principal Investigator: Florence Campeotto, MD AP-HP
Assistance Publique - Hôpitaux de Paris
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP