Protein IntoleranceNCT03698058
A2 GUM Post-Market Effectiveness Study
A study testing Toddler milk in people with Protein Intolerance, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Protein Intolerance
- What is being tested?
- Toddler milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2018to 31 Mar 2019
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
- Children 12 - 36 months of age at enrolment.
- Children who have been born full-term (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- Children who are habitually consuming some cow's milk, other traditional milks (including non-A2 GUMs, kids' milk, white milk, flavored milk) and/or dairy or non-dairy alternative milks (such as those sourced from goats, sheep, soy, rice, coconut, and nut).
- Child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study protocol.
Who cannot join
- Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures.
- Known and diagnosed cow's milk protein allergy.
- Children currently using or having ever used specialty infant formula and/or GUMs such as hypoallergenic (HA), lactose-free, or anti-regurgitation formulas.
- Children who have known cognitive and developmental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Reproductive and Child Health, Peking University
Beijing
About this study
Official title: Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China
This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.
Read the detailed description
This post-market study primarily aims to assess the real-life effectiveness of a newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and GI-related behaviors compared with other milk products and milk alternatives.
- Conditions
- Protein Intolerance
- Being tested
- Toddler milk
- Keywords
- Nutrition, Toddlers, A2, B-casein, Gut comfort, Growing up milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toddler milkDietary supplement
Commercially available toddler milk
| Study group | Role | What they receive |
|---|---|---|
| A2 Growing Up Milk | Experimental | Not described Receives: Dietary Supplement: Toddler milk |
| Traditional non-A2 milk | No intervention | Not described |
| Other Growing Up Milk | Active comparator | Not described Receives: Dietary Supplement: Toddler milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall digestive comfort
Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).
Measured: Baseline to Study Day 14
Secondary outcomes (7)
Stool frequency
Stool frequency reported by parents in 3-Day GI Symptoms Diary
Measured: Baseline, Study Day 7, Study Day 14
Stool consistency
Stool consistency score reported by parents in 3-Day GI Symptoms Diary
Measured: Baseline, Study Day 7, Study Day 14
Consumption of other milk products
Reported by parents on 3 consecutive days on Milk Intake Diary
Measured: Baseline, Study Day 7, Study Day 14
Child weight
Weight as measured by study staff in health clinic
Measured: Baseline, Study Day 7, Study Day 14
Child height
Weight as measured by study staff in health clinic
Measured: Baseline, Study Day 7, Study Day 14
Child head circumference
Head circumference as measured by study staff in health clinic
Measured: Baseline, Study Day 7, Study Day 14
Adverse events
All adverse events reported by parents and confirmed by study investigator
Measured: Baseline to Study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start15 Sep 2018
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein IntoleranceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 387 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
- NCT03698058
- Sponsor's protocol ID
- 18.14.INF
- Status last verified
- Jul 2020
- First submitted
- 4 Oct 2018
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China
- ClinicalTrials.gov ID
- NCT03698058
- Acronym / sponsor ID
- 18.14.INF
- Conditions
- Protein Intolerance
- Keywords
- Nutrition, Toddlers, A2, B-casein, Gut comfort, Growing up milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 5 Oct 2018 (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 post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.
Detailed description
This post-market study primarily aims to assess the real-life effectiveness of a newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and GI-related behaviors compared with other milk products and milk alternatives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A2 Growing Up Milk | Experimental | Dietary Supplement: Toddler milk |
| Traditional non-A2 milk | No intervention | – |
| Other Growing Up Milk | Active comparator | Dietary Supplement: Toddler milk |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
- Children 12 - 36 months of age at enrolment.
- Children who have been born full-term (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- Children who are habitually consuming some cow's milk, other traditional milks (including non-A2 GUMs, kids' milk, white milk, flavored milk) and/or dairy or non-dairy alternative milks (such as those sourced from goats, sheep, soy, rice, coconut, and nut).
- Child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study protocol.
Key exclusion criteria (4 listed)
- Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures.
- Known and diagnosed cow's milk protein allergy.
- Children currently using or having ever used specialty infant formula and/or GUMs such as hypoallergenic (HA), lactose-free, or anti-regurgitation formulas.
- Children who have known cognitive and developmental 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 milkCommercially available toddler milk | Dietary supplement | A2 Growing Up Milk, Other Growing Up Milk |
Primary outcome
Overall digestive comfort
Time frame: Baseline to Study Day 14
Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).
7 secondary outcomes
Stool frequency
Time frame: Baseline, Study Day 7, Study Day 14
Stool consistency
Time frame: Baseline, Study Day 7, Study Day 14
Consumption of other milk products
Time frame: Baseline, Study Day 7, Study Day 14
Child weight
Time frame: Baseline, Study Day 7, Study Day 14
Child height
Time frame: Baseline, Study Day 7, Study Day 14
Child head circumference
Time frame: Baseline, Study Day 7, Study Day 14
Adverse events
Time frame: Baseline to Study Day 14
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 7 Jul 2020.
- 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 Protein Intolerance, 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 4 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 7 Jul 2020. 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?
Overall digestive comfort (time frame: Baseline to Study Day 14). 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 7 Jul 2020.