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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Digestion, Happiness, Temperament

Intervention / Treatment
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* Dietary Supplement: Toddler Milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 33 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toddler Milk Group<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperament | Change in temperament surgency scores derived from the Children's Behavior Questionnaire (CBQ), short version | from baseline (week 0) to week 4 (Day 28±2) | 
| Child's emotional expressions | 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. | at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2). | 
| Milk Satisfaction | 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. | at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2). | 
| Weight in kilograms | Weight (kg) will be taken for the purpose of assessing child's growth | at week 0 (baseline) and week 4 (Day 28±2) | 
| Height in centimeters | Height (cm) will be taken for the purpose of assessing child's growth | at week 0 (baseline) and week 4 (Day 28±2) | 
| Milk intake | based on 24-hour recall of dairy and non-dairy intake obtained from the Milk Intake Questionnaire | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prebiotic, digestion, child development, temperament