DigestionNCT04768933
Parental Notions and Clinical Experiences About Child's Gut Comfort, Overall Satisfaction and Sense of Well-being When Consuming a New Toddler Milk
A study testing Toddler Milk in people with Digestion and Happiness, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 33 monthsHealthy volunteers can take part
- Conditions the study is for
- Digestion, Happiness, Temperament
- What is being tested?
- Toddler Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2020to 12 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 33 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Information Technology co., LTD
Shanghai, 200000
About this study
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).
Read the 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.
- Conditions
- Digestion, Happiness, Temperament
- Being tested
- Toddler Milk
- Keywords
- prebiotic, digestion, child development, temperament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toddler MilkDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Toddler Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) and week 4 (Day 28±2)
Secondary outcomes (6)
Temperament
Change in temperament surgency scores derived from the Children's Behavior Questionnaire (CBQ), short version
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start11 Oct 2020
- Primary completion28 Nov 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DigestionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768933
- Sponsor's protocol ID
- 20.14.INF
- Status last verified
- Feb 2021
- First submitted
- 17 Dec 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04768933
- Acronym / sponsor ID
- 20.14.INF
- Conditions
- Digestion, Happiness, Temperament
- Keywords
- prebiotic, digestion, child development, temperament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toddler Milk Group | Experimental | Dietary Supplement: Toddler MilkAll 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. |
Who may qualify
- Ages
- 12 to 33 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toddler MilkAt 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). | Dietary supplement | Toddler Milk Group |
Primary outcome
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.
6 secondary outcomes
Temperament
Time frame: from baseline (week 0) to week 4 (Day 28±2)
Child's emotional expressions
Time frame: at weeks 0 (baseline), 1 (Day 7±2), 2 (Day 14±2), and 4 (Day 28±2).
Milk Satisfaction
Time frame: at weeks 0 (baseline), 1 (Day 7±2) and 4 (Day 28±2).
Weight in kilograms
Time frame: at week 0 (baseline) and week 4 (Day 28±2)
Height in centimeters
Time frame: at week 0 (baseline) and week 4 (Day 28±2)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toddler Milk in people with Digestion and Happiness, run by Société des Produits Nestlé (SPN) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digestive tolerance (time frame: Baseline (week 0) and week 4 (Day 28±2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.