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

Preterms With Gestational Age Ranging From 30 to 35 Weeks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711633
• Other study ID #: 1977/06-05-02
• Status: Completed
• Phase: N/A
• First received: July 4, 2008
• Last updated: July 4, 2008
• Start date: December 2002
• Est. completion date: June 2007

Study information

• Verified date: June 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2007
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Preterms With Gestational Age Ranging From 30 to 35 Weeks

Intervention

Dietary Supplement:
• Milk with probiotic and prebiotic activities
Comparison of two different formula for preterm infants
• Milk without probiotic and prebiotic activities
Comparison of formula for preterm infants

Locations

Country	Name	City	State
France	Neonatat unit, Saint Vincent de Paul Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Blédina SA, Villefranche sur Saône, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up of the number of colonized infants and the bacterial colonization levels		weekly until hospital discharge	Yes
Secondary	Clinical tolerance		weekly until hospital discharge	Yes
Secondary	Levels of intestinal immune and inflammatory markers		weekly until hospital discharge	Yes