Growth Clinical Trial
Official title:
Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
This prospective, randomized, double blind, controlled study evaluated the safety and effect
on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and
containing a symbiotic, in term infants.
Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose
formula feeding were enrolled during their first eight days of life.
Both parents provided informed written consent. Infants were randomly assigned to receive
either the new test formula or a control, a regular formula adapted for term infants
(Modilac®1). The control formula is formulated to meet the nutritional needs of infants.
For each neonates, neonatal parameters were collected.
5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5
(6 months). During each visit, the investigator filled in observational book the
anthropometric parameters (weight, height, head circumference, BMI) and pieces of
information collected 3 days before by the parents (gastrointestinal tolerance parameters,
daily infant behaviour and milk consumption). Global parents' contentment was evaluated as
well.
In two investigation centers, at the end of the 6th month, immuno-allergic test was
realised.
Stools were collected at the end of the first and sixth month from diapers, for
microbiological analysis and measurements of faecal inflammatory markers.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05551975 -
Preterm Infants Fed a Human Milk Fortifier
|
N/A | |
| Completed |
NCT01162798 -
Preterm Infant Growth
|
N/A | |
| Completed |
NCT01721512 -
The Growth and Development of Breast and Formula Fed Term Asian Infants
|
N/A | |
| Active, not recruiting |
NCT00970398 -
Effect of an Infant Formula on Infant Growth, Health and Immune Functions
|
N/A | |
| Completed |
NCT01666457 -
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
|
||
| Completed |
NCT00808756 -
Study on Fermentable Carbohydrates in Healthy Infants
|
N/A | |
| Completed |
NCT00997971 -
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
|
Phase 3 | |
| Completed |
NCT03276663 -
Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula
|
N/A | |
| Recruiting |
NCT02695784 -
Probiotics After Discharge
|
Phase 4 | |
| Withdrawn |
NCT02860026 -
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
|
N/A | |
| Completed |
NCT01128517 -
Maternal Education on Complementary Feeding and Infant Outcome
|
N/A | |
| Completed |
NCT00282113 -
Effects of Probiotic and Prebiotic Combinations on Premature Infants
|
N/A | |
| Completed |
NCT03276884 -
Growth and Tolerance of Young Infants
|
N/A | |
| Completed |
NCT04055363 -
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
|
N/A | |
| Completed |
NCT05302427 -
Infant Massage and Infant Growth, Mother-Infant Attachment, and Maternal Self-Confidence
|
N/A | |
| Not yet recruiting |
NCT05616117 -
Next-generation Effects of Vitamin D Supplementation in Pregnancy
|
||
| Active, not recruiting |
NCT02410057 -
Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula
|
N/A | |
| Completed |
NCT01109849 -
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
|
Phase 4 | |
| Completed |
NCT01158352 -
Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children
|
N/A | |
| Completed |
NCT01210391 -
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
|
N/A |