Healthy ChildrenNCT06287385
An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits
A study testing Goat-milk Based Formula in people with Healthy Children, run by Danone Nutricia at 1 site in China.
Trial summary
This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives. Read more about this study
- Who is it for?
- Ages 1 year to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Goat-milk Based Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 31 Dec 2024
- 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 1 year to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 1-2 years of age
- Healthy term infants, gestational ages 37~42 weeks
- Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart);
- Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart)
- Chinese population;
- Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period;
Show all 10Show fewer
- Informed consent from one parent or legal representative;
- Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents;
- Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires;
- Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.
Who cannot join
- Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment;
- Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment;
- Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.;
- Known allergy to milk products or soy product;
- Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc;
- Significant congenital abnormality or other health conditions that could affect the outcome measurements;
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
- Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Real-world Study to Explore the Effects of a Goat-milk Based Formula on Gut Health and Related Health Benefits in Healthy, Term-born Chinese Young Children
This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.
- Conditions
- Healthy Children
- Being tested
- Goat-milk Based Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goat-milk Based FormulaDietary supplement
Provided Goat-milk Based Formula for babies 1-2 years old
| Study group | Role | What they receive |
|---|---|---|
| Formula fed | Experimental | Goat-milk Based Formula (Stage 3) Receives: Dietary Supplement: Goat-milk Based Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool characteristics
Stool characteristics assessed with BITSS
Measured: before and 7, 14, 21 and 28 days after administration of the investigational product
Secondary outcomes (3)
Gastrointestinal symptoms
Gastrointestinal symptoms assessed with Gastrointestinal Symptom Questionnaire
Measured: before and 7, 14, 21 and 28 days after administration of the investigational product
Quality of life of subjects
Quality of life of subjects assessed with Pediatric Quality of Life Inventory (PedsQL)
Measured: before and 28 days after administration of the investigational product
Lifestyle-related immune indicators
Lifestyle-related immunity status reported by parents or medically diagnosed (indicated in the subject's medical file)
Measured: before and 28 days after administration of the investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start28 Mar 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zailing Li, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287385
- Sponsor's protocol ID
- NELN202212A
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2024
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Real-world Study to Explore the Effects of a Goat-milk Based Formula on Gut Health and Related Health Benefits in Healthy, Term-born Chinese Young Children
- ClinicalTrials.gov ID
- NCT06287385
- Acronym / sponsor ID
- NELN202212A
- Conditions
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Mar 2024 (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 an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formula fed | Experimental | Dietary Supplement: Goat-milk Based FormulaGoat-milk Based Formula (Stage 3) |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age between 1-2 years of age
- Healthy term infants, gestational ages 37~42 weeks
- Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart);
- Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart)
- Chinese population;
Key exclusion criteria (8 listed)
- Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment;
- Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment;
- Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.;
- Known allergy to milk products or soy product;
- Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc;
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 |
|---|---|---|
| Goat-milk Based FormulaProvided Goat-milk Based Formula for babies 1-2 years old | Dietary supplement | Formula fed |
Primary outcome
Stool characteristics
Time frame: before and 7, 14, 21 and 28 days after administration of the investigational product
Stool characteristics assessed with BITSS
3 secondary outcomes
Gastrointestinal symptoms
Time frame: before and 7, 14, 21 and 28 days after administration of the investigational product
Quality of life of subjects
Time frame: before and 28 days after administration of the investigational product
Lifestyle-related immune indicators
Time frame: before and 28 days after administration of the investigational product
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 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Children
Active, not recruiting
Pediatric Parenting Support in Flint
Healthy, Family Research
RecruitingObservational study
An International Federated Model for Wearable-derived Remote Longitudinal Motor Monitoring in Young Children With Spinal Muscular Atrophy Compared With Healthy Controls: Active-NBS Study (UK)
Spinal Muscular Atrophy (SMA)
RecruitingObservational study
Pregnancy 24/7 Offspring Study
Healthy
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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.
Zailing Li, PhD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goat-milk Based Formula in people with Healthy Children, run by Danone Nutricia 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 10 inclusion and 8 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 5 Aug 2025. 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?
Stool characteristics (time frame: before and 7, 14, 21 and 28 days after administration of the investigational product). 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 5 Aug 2025.