This Study Focused on the Incidence of Infant Allergy and Various Disease, Supported by Data on 16S rRNA Gut Microbiota and Untargeted MetabolomicsolomeNCT07886437
Study on the Impact of Different Feeding Methods on Allergy Prevention and Digestive Absorption in Infants and Young Children：A Mixed Study
An observational study of This Study Focused on the Incidence of Infant Allergy and Various Disease, Supported by Data on 16S rRNA Gut Microbiota and Untargeted Metabolomicsolome, run by Tsinghua University at 1 site in China.
Trial summary
Based on a real-world research paradigm, this study aims to evaluate the performance of infants fed via different methods-specifically goat milk formula, control formula, and breastfeeding-regarding allergy prevention and protein digestion and absorption. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- This Study Focused on the Incidence of Infant Allergy and Various Disease, Supported by Data on 16S rRNA Gut Microbiota and Untargeted Metabolomicsolome
- What is being tested?
- Observation and biological sample collection: stool
- How many people
- 696 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study focused on full-term birth infants aged 0-6 months with an Apgar score ≥8 at birth, and exclude those individuals with congenital malformations, metabolic disorders, or immune disorders. Specifically, concerning the subpopulations for stool sample collection, the study would also exclude those who took probiotics in the past four weeks.
Who may be able to join
- Aged 0-6 months
- Full-term birth
- Apgar score ≥8 at birth
Who cannot join
- Individuals with congenital malformations, metabolic disorders, or immune disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed Study Based on the Effects of Different Feeding Methods on Allergy Prevention and Digestive Absorption Among Infants and Toddlers.
Based on a real-world research paradigm, this study aims to evaluate the performance of infants fed via different methods-specifically goat milk formula, control formula, and breastfeeding-regarding allergy prevention and protein digestion and absorption. The study begins with a cross-sectional survey to compare differences among these groups in terms of allergy-related markers, stool characteristics, and feeding difficulties. Subsequently, a prospective follow-up cohort study will be conducted based on these real-world feeding groups to monitor the incidence of allergies and other related data; stool samples will also be collected to analyze markers associated with protein digestion.
- Being tested
- Observation, biological sample collection: stool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Collect questionnaire information.
biological sample collection: stoolOther
Collect the stool sample from selected participants under standard instruction
| Study group | Role | What they receive |
|---|---|---|
| goat milk formula group | Not described Receives: Other: Observation; Other: biological sample collection: stool | |
| control formula group | Not described Receives: Other: Observation; Other: biological sample collection: stool | |
| breastfeeding group | Not described Receives: Other: Observation; Other: biological sample collection: stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infant allergy, respiratory disease, digestive disease
Measured: Enrollment and 3 follow-up time points
Feeding Assessment Scales
Measured: Enrollment and 3 follow-up time points
16s RNA gut microbiota
Measured: Enrollment and 3 follow-up time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Mar 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Focused on the Incidence of Infant Allergy and Various Disease, Supported by Data on 16S rRNA Gut Microbiota and Untargeted MetabolomicsolomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 696 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia Yili Industrial Group Co., Ltd
- Responsible party
- Principal investigator, Ai Zhao, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886437
- Sponsor's protocol ID
- THU-01-2026-0009
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Study Based on the Effects of Different Feeding Methods on Allergy Prevention and Digestive Absorption Among Infants and Toddlers.
- ClinicalTrials.gov ID
- NCT07886437
- Acronym / sponsor ID
- THU-01-2026-0009
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 696 participants (estimated)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Collaborators
- Inner Mongolia Yili Industrial Group Co., Ltd
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
Based on a real-world research paradigm, this study aims to evaluate the performance of infants fed via different methods-specifically goat milk formula, control formula, and breastfeeding-regarding allergy prevention and protein digestion and absorption. The study begins with a cross-sectional survey to compare differences among these groups in terms of allergy-related markers, stool characteristics, and feeding difficulties. Subsequently, a prospective follow-up cohort study will be conducted based on these real-world feeding groups to monitor the incidence of allergies and other related data; stool samples will also be collected to analyze markers associated with protein digestion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| goat milk formula group | – | Other: Observation, Other: biological sample collection: stool |
| control formula group | – | Other: Observation, Other: biological sample collection: stool |
| breastfeeding group | – | Other: Observation, Other: biological sample collection: stool |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study focused on full-term birth infants aged 0-6 months with an Apgar score ≥8 at birth, and exclude those individuals with congenital malformations, metabolic disorders, or immune disorders. Specifically, concerning the subpopulations for stool sample collection, the study would also exclude those who took probiotics in the past four weeks.
Key inclusion criteria (3 listed)
- Aged 0-6 months
- Full-term birth
- Apgar score ≥8 at birth
Key exclusion criteria (1 listed)
- Individuals with congenital malformations, metabolic disorders, or immune 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 |
|---|---|---|
| ObservationCollect questionnaire information. | Other | breastfeeding group, control formula group, goat milk formula group |
| biological sample collection: stoolCollect the stool sample from selected participants under standard instruction | Other | breastfeeding group, control formula group, goat milk formula group |
Primary outcome
Incidence of infant allergy, respiratory disease, digestive disease
Time frame: Enrollment and 3 follow-up time points
Feeding Assessment Scales
Time frame: Enrollment and 3 follow-up time points
16s RNA gut microbiota
Time frame: Enrollment and 3 follow-up time points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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?
An observational study of This Study Focused on the Incidence of Infant Allergy and Various Disease, Supported by Data on 16S rRNA Gut Microbiota and Untargeted Metabolomicsolome, run by Tsinghua University 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of infant allergy, respiratory disease, digestive disease (time frame: Enrollment and 3 follow-up time points). The study lists 3 primary outcomes in all. 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 21 Oct 2026.