Study evaluating the effects of an infant formula on physical growth in healthy term infants
- Conditions
- Healthy infants
- Registration Number
- NL-OMON22324
- Lead Sponsor
- Danone Nutricia Research
- Brief Summary
<after study completion, add references to publication(s) of the results of the study in consultation with stakeholders>
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy, singleton, term born infants with gestational age of 37 – 42 weeks. 2. Infants aged = 14 days at enrollment. 3. Birth weight within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards. 4. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. 5. Written informed consent (IC) from parent(s) and/or legal guardian(s) aged =18 years at screening.
1. Infants known or suspected to have cow's milk allergy, fish protein allergy, soy allergy and/or lactose intolerance. 2. Infants with current or previous illnesses/conditions which could interfere with the study outcomes, as assessed by the investigator. 3. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is weight gain (grams per day) [Time frame: enrollment to 16 weeks of intervention]</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Weight [Time frame: enrollment to 16 weeks of intervention] Weight gain in grams/ day 2. Length [Time frame: enrollment to 16 weeks of intervention] Length gain in cm/ day 3. Head circumference [Time frame: enrollment to 16 weeks of intervention] Head circumference gain in cm/ day 4. Study product intake [Time frame: enrollment to 16 weeks of intervention] Parent completed diary 5. Gastrointestinal tolerance [Time frame: enrollment to 16 weeks of intervention] Parent completed diary 6. Adverse events [Time frame: enrollment to 16 weeks of intervention] Standard adverse event reporting Other outcomes 1. Infant stool characteristics [Time frame: enrollment to 16 weeks of intervention] Parent completed diary 2. Infant stool microbiota composition and functionality [Time frame: enrollment to 16 weeks of intervention] Stool sampling 3. Study product appreciation questionnaire [Time frame: enrollment to 16 weeks of intervention] Parent completed questionnaire</p><br>