Clinical trial NCT04768933: Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
Official title: Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestion
Happiness
Temperament
Keywords: prebiotic
digestion
child development
temperament
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 have shown to be able to improve digestive comfort and milk taste. Physiological factors such as physical discomfort has been shown to be associated with negative emotionality and temperament (Putnam 2012). Therefore, the investigators hypothesize that by improving digestive comfort, they are able to influence child temperament, happiness, and other behavioral characteristics.

Eligibility criteria: Inclusion Criteria:

1. Generally healthy toddlers born at term (37-42 weeks of gestation).
2. At enrolment visit, toddler age 12-33 months.
3. Birth weight ≥ 2500g and ≤ 4500g.
4. No known milk intolerance / allergies to cow's milk protein.
5. Habitually consuming some cow's milk or other traditional milks.

Exclusion Criteria:

1. Toddler is currently breastfed or is consuming breast milk.
2. Toddler who is experiencing growth faltering (defined as weight for length z score ≤-1.67).
3. History of preterm birth
4. Currently experiencing severe constipation.
5. Currently diagnosed with other Functional Gastrointestinal Disorders.
6. Toddlers who have known cognitive and developmental disorders.
7. Toddlers who are currently participating in or have participated in another clinical trial within 4 weeks prior to trial start.

Primary outcomes:
measure: Digestive tolerance
timeFrame: Baseline (week 0) and week 4 (Day 28±2)
Secondary outcomes:
measure: Temperament
timeFrame: from baseline (week 0) to week 4 (Day 28±2)
measure: Child's emotional expressions
timeFrame: at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2).
measure: Milk Satisfaction
timeFrame: at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2).
measure: Weight in kilograms
timeFrame: at week 0 (baseline) and week 4 (Day 28±2)
measure: Height in centimeters
timeFrame: at week 0 (baseline) and week 4 (Day 28±2)
measure: Milk intake
timeFrame: at baseline and prospectively during transition period (Day 1-3) and for three consecutive days on week 1 (Day 7±2), 2 (Day 14±2) and 4 (Day 28±2).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Information Technology co., LTD
Study officials:
References: