CompletedNot Applicable

Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk

China100 participantsStarted 2020-10-11

Plain-language 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).

Who can participate

Age range12 Months – 33 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Digestive tolerance

Timeframe: Baseline (week 0) and week 4 (Day 28±2)

Trial details

NCT IDNCT04768933

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-28

View on ClinicalTrials.gov More Digestion trials