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OpenTrials
Completed

NCT Number: NCT04768933

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

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).

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Key information

Age range

12 month–33 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai China-norm Information Technology co., LTD

Shanghai, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Digestive tolerance

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

    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.

Secondary outcomes

  1. Temperament

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

    Change in temperament surgency scores derived from the Children's Behavior Questionnaire (CBQ), short version

  2. Child's emotional expressions

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

    Child's emotional expressions such as Happy, Smiling, Surprised, Anger, and Disgust derived from the Anura phone app. In addition, parents will report child's mood including being happy, relaxed and smiling in the Mood Diary.

  3. Milk Satisfaction

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

    Milk Satisfaction derived from a toddler and parent-reported brief (9-items) Milk Satisfaction Questionnaire The questionnaire consists of questions regarding taste, sweetness, milky taste, nutritional profile, and convenience.

  4. Weight in kilograms

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

    Weight (kg) will be taken for the purpose of assessing child's growth

  5. Height in centimeters

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

    Height (cm) will be taken for the purpose of assessing child's growth

  6. Milk intake

    Time frame: 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).

    based on 24-hour recall of dairy and non-dairy intake obtained from the Milk Intake Questionnaire

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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