Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of I… (NCT02239588) | Clinical Trial Compass
CompletedPhase 4
Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age
China120 participantsStarted 2014-04
Plain-language summary
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with a 12-week intervention period.
The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6 months) milk powder on:
1. Bone health;
2. Infants growth;
3. Intestinal health;
4. Gastrointestinal tolerance to the test product;
g) Incidence of Eczema
Who can participate
Age range7 Days – 90 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants 7\~90 days old;
* Fed by breast milk before enrollment;
* Concent form signed by parents
Exclusion Criteria:
* Twins, multiple births, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
* During pregnancy, the mothers had pregnancy complications or other disease that may affect the study results;
* Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other diseases;
* Having neonatal diarrhea or acute respiratory infections within 48 hours before enrollment;
* Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
* Having taken any food containing prebiotics or probiotics within 15 days of enrollment;
* Having gluten allergy (celiac disease);
* Body weight-to-height Z-value \<-3 according to the standard of WHO;
* Receiving hormone therapy and intravenous nutrition;
* Lactose intolerance;
* Have participated in other clinical studies within 3 months prior to the date of screening;
* Unable to comply the study schedule
What they're measuring
1
Bone density change from baseline (Tibial speed of sound measurement)