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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711633
First Posted: July 9, 2008
Last Update Posted: July 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Blédina SA, Villefranche sur Saône, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Preterms With Gestational Age Ranging From 30 to 35 Weeks Dietary Supplement: Milk with probiotic and prebiotic activities Dietary Supplement: Milk without probiotic and prebiotic activities

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Follow-up of the number of colonized infants and the bacterial colonization levels [ Time Frame: weekly until hospital discharge ]

Secondary Outcome Measures:
  • Clinical tolerance [ Time Frame: weekly until hospital discharge ]
  • Levels of intestinal immune and inflammatory markers [ Time Frame: weekly until hospital discharge ]

Enrollment: 58
Study Start Date: December 2002
Study Completion Date: June 2007
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
the fermented preterm formula (FPF)
Dietary Supplement: Milk with probiotic and prebiotic activities
Comparison of two different formula for preterm infants
Placebo Comparator: 2
formula adapted for preterm infants (PF)
Dietary Supplement: Milk without probiotic and prebiotic activities
Comparison of formula for preterm infants
Other Name: Comparison of formula for 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711633


Locations
France
Neonatat unit, Saint Vincent de Paul Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Blédina SA, Villefranche sur Saône, France
Investigators
Principal Investigator: Florence Campeotto, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Serreau, URC Paris Centre
ClinicalTrials.gov Identifier: NCT00711633     History of Changes
Other Study ID Numbers: 1977/06-05-02
First Submitted: July 4, 2008
First Posted: July 9, 2008
Last Update Posted: July 9, 2008
Last Verified: June 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Premature birth,
infant,
infant formula,
bacterial colonization,
Bifidobacterium,
calprotectin

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications