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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:
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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
Other Name: Milk with probiotic and prebiotic activities
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

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 AP-HP
  More Information

Publications:
Responsible Party: Serreau, URC Paris Centre
ClinicalTrials.gov Identifier: NCT00711633     History of Changes
Other Study ID Numbers: 1977/06-05-02
Study First Received: July 4, 2008
Last Updated: July 4, 2008
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on November 24, 2014