Clinical trial NCT01010113: Effects of a Synbiotics-containing Starter Formula on Infant Growth
Official title: Growth of Infants Consuming Starter Formula Containing Synbiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: infants
prebiotics
probiotics
safety
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: National University Hospital, Singapore
First posted: 2009-11-09
Enrollment: 140
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.

Detailed description: Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.

The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.

Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.

Eligibility criteria: Inclusion Criteria:

* Healthy newborn infant
* Age at point of enrolment ≤14 days
* Birthweight ≥2500g and ≤4500g
* Full term infant ≥37 weeks gestation and ≤42 weeks gestation
* Singleton births
* Having obtained his/her or his/her legal representative's informed consent

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth
* Significant pre-natal or post-natal disease
* Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
* Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
* Patient who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial prior to the beginning of this study

Primary outcomes:
measure: mean weight gain
timeFrame: 6 months
Secondary outcomes:
measure: digestive tolerance
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Dr. Lee Le Ye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee le Y, Bharani R, Biswas A, Lee J, Tran LA, Pecquet S, Steenhout P. Normal growth of infants receiving an infant formula containing Lactobacillus reuteri, galacto-oligosaccharides, and fructo-oligosaccharide: a randomized controlled trial. Matern Health Neonatol Perinatol. 2015 Apr 7;1:9. doi: 10.1186/s40748-015-0008-3. eCollection 2015.