Skip to main content
OpenTrials
Completed

NCT Number: NCT01983072

Symbiotic & Colonization

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Nord, Marseille, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant Formula

Dietary Supplement

breastfeeding

Other

Breastfeeding

Primary outcomes

  1. stool bacterial populations

    Time frame: 3 months

    (Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.

Secondary outcomes

  1. changes in weight

    Time frame: 3 months

    weight

  2. Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)

    Time frame: 3 months

    Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)

  3. changes in length

    Time frame: 3 months

    changes in length

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of Starter Formula With Symbiotic on Microbiota Balance

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.