Symbiotic & Colonization

Phase 2

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Infant formula; Other: Breastfeeding

• Registration Number: NCT01983072
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

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 Timeline

• Study Start: 2008-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2013-10-29
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-12
• Last Update Submitted: 2013-11-12
• Study First Posted: 2013-11-13
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant starter formula + prebiotics + probiotics	Infant formula	infant formula
Breastfeeding group	Breastfeeding	reference group
Infant starter formula	Infant formula	standard infant formula

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
changes in weight	3 months	weight
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)	3 months	Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
changes in length	3 months	changes in length

Trial Locations

Locations (4)

The Medical University of Warsaw; 🇵🇱 Warsaw, Poland

Hôpital Saint Joseph; 🇫🇷 Marseille, France

Hôpital de la Conception; 🇫🇷 Marseille, France

Hôpital Nord; 🇫🇷 Marseille, France