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.
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Notify MeKey information
Conditions
Age range
Up to 4 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Hôpital Nord, Marseille, France
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
breastfeeding
OtherBreastfeeding
Primary outcomes
-
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
-
changes in weight
Time frame: 3 months
weight
-
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)
-
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.
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