Symbiotic & Colonization

Effect of Starter Formula With Symbiotic on Microbiota Balance

The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Infant formula; Other: Breastfeeding

Detailed Description

The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13015
    • Hopital Nord
  • Marseille, France, 13008
    • Hôpital Saint Joseph
  • Marseille, France, 13015
    • Hôpital de la Conception
• Poland
  • Warsaw, Poland, 01-184
    • The Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy newborn infant
• Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
• Age of infant is between 14 days at the time of enrollment
• Birth weight between 2500g and 4500g
• For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Congenital illness or malformation that may affect normal growth
• Significant pre-natal and/or post-natal disease
• Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
• Newborn who have received antibiotics during the first 14 days of life
• Receiving infant formula containing pro and/or prebiotics at the time of enrolment
• Newborn whose parents / caregivers cannot be expected to comply with treatment
• Newborn currently participating in another clinical trial

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infant starter formula; standard infant formula	Dietary supplement: Infant formula
Experimental: Infant starter formula + prebiotics + probiotics; infant formula	Dietary supplement: Infant formula
Other: Breastfeeding group; reference group	Other: Breastfeeding; Breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stool bacterial populations	(Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in weight	weight	3 months
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)	Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)	3 months
changes in length	changes in length	3 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Hania Szajewska, The Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: colonization of the gastrointestinal tract with bacteria
• Other Study ID Numbers: 06.08.INF