Status:
COMPLETED
Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Digestion
Happiness
Eligibility:
All Genders
12-33 years
Phase:
NA
Brief Summary
This is a prospective, open-label, single-arm study in a real-world setting of healthy Chinese toddlers provided with new toddler milk for a total of 4 weeks (28 days).
Detailed Description
The new toddler milk contains prebiotic and an optimized fat blend of bovine milk fat, vegetable fats, and a LC-PUFA oil mixture (providing DHA and ARA). The prebiotic and bovine milk fat-based blend ...
Eligibility Criteria
Inclusion
- Generally healthy toddlers born at term (37-42 weeks of gestation).
- At enrolment visit, toddler age 12-33 months.
- Birth weight ≥ 2500g and ≤ 4500g.
- No known milk intolerance / allergies to cow's milk protein.
- Habitually consuming some cow's milk or other traditional milks.
Exclusion
- Toddler is currently breastfed or is consuming breast milk.
- Toddler who is experiencing growth faltering (defined as weight for length z score ≤-1.67).
- History of preterm birth
- Currently experiencing severe constipation.
- Currently diagnosed with other Functional Gastrointestinal Disorders.
- Toddlers who have known cognitive and developmental disorders.
- Toddlers who are currently participating in or have participated in another clinical trial within 4 weeks prior to trial start.
Key Trial Info
Start Date :
October 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04768933
Start Date
October 11 2020
End Date
December 12 2020
Last Update
February 24 2021
Active Locations (1)
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1
Shanghai China-norm Information Technology co., LTD
Shanghai, China, 200000