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

NCT04768933 | Completed

• 1 other identifier: 20.14.INF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Digestion; Happiness; Temperament

Keywords

prebiotic; digestion; child development; temperament

Outcome Measures

Primary Outcomes (1)

• Digestive tolerance

  Change in overall digestive tolerance composite scores measured by the Toddler Gut Comfort Questionnaire consisting of 10 questions on parent perceptions of constipation, diarrhea, gassiness, abdominal pain, bloating and other GI-related behaviors.

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

Secondary Outcomes (6)

• Temperament

  from baseline (week 0) to week 4 (Day 28±2)

• Child's emotional expressions

  at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2).

• Milk Satisfaction

  at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2).

• Weight in kilograms

  at week 0 (baseline) and week 4 (Day 28±2)

• Height in centimeters

  at week 0 (baseline) and week 4 (Day 28±2)

Study Arms (1)

Toddler Milk Group

EXPERIMENTAL

All enrolled subjects with be provided a new toddler milk for 28 days. Aligned with clinical and label recommendations, they will be required to intake at least 3 servings of 130 ml per day.

Dietary Supplement: Toddler Milk

Interventions

Toddler Milk DIETARY_SUPPLEMENT

At least three 130 mL servings daily of study formula are recommended for a total daily intake of 390 mL. Study participants will continue this feeding regimen Days 4 to 28 (approximately 4 weeks).

Toddler Milk Group

Eligibility Criteria

• Age: 12 Months - 33 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Shanghai China-norm Information Technology co., LTD

Shanghai, 200000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: February 24, 2021
• Study Start: October 11, 2020
• Primary Completion: November 28, 2020
• Study Completion: December 12, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)