Infant GrowthNCT07534735
Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial
A study testing Investigational Formula 1 and Investigational Formula 2 in people with Infant Growth, run by Biostime (Changsha) Nutrition Foods Limited at 1 site in China.
Trial summary
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Growth
- What is being tested?
- Investigational Formula 1 and Investigational Formula 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2026to Jan 2027
- Phase
- Interventional
- 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy full-term infants (gestational age 37-42 weeks).
- Age 12-18 months (inclusive).
- Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old".
- Has started or plans to start stage 3 formula feeding before enrollment.
- Guardian voluntarily signs written informed consent and is able to comply with all study procedures including regular visits, intervention plan, and laboratory tests.
Who cannot join
- Known allergy to milk protein or the study formula.
- Known allergic constitution or high allergy risk (parent with allergic constitution).
- Malnutrition assessed by investigator.
- Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development.
- History of preterm birth or admission to Neonatal Intensive Care Unit (NICU), excluding phototherapy for jaundice.
- Severe constipation or diagnosis of other functional gastrointestinal disorders.
- Cognitive or developmental disorders.
- Any other condition that, in the investigator's judgment, makes the infant unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen University
Shenzhen, Guangdong, 518060
Pantian Huang, +86 13430375474, umi.huang@hh.global
Siwan Peng, +86 13543117452, pengsiwan@zhunter.com.cn
About this study
Official title: Growth, Gut Health, Immune Function, and Sleep Status in Infants and Young Children Fed With Novel Infant Formula : A Randomized Trial
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
- Conditions
- Infant Growth
- Being tested
- Investigational Formula 1, Investigational Formula 2
- Keywords
- Human Milk Oligosaccharides, Infant Formula, Infant Growth, Gut Health, Immune Function, Sleep, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Formula 1Dietary supplement
The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
Investigational Formula 2Dietary supplement
The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
| Study group | Role | What they receive |
|---|---|---|
| Investigational Formula 1 | Experimental | Not described Receives: Dietary Supplement: Investigational Formula 1 |
| Investigational Formula 2 | Experimental | Not described Receives: Dietary Supplement: Investigational Formula 2 |
| Control: Commercial Infant Formula or Dairy Products | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Height
Measured in centimeters (cm)
Measured: Baseline (Day -7) to Day 90
Change in Weight
Measured in kilograms (kg)
Measured: Baseline (Day -7) to Day 90
Comprehensive Nutritional Development Assessment
(1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ).
Measured: Baseline (Day -7) to Day 90
Secondary outcomes (10)
Change in Salivary sIgA
Saliva sample collected in microliters (µL)
Measured: Baseline (Day -7) to Day 90
Change in Salivary Lysozyme
Saliva sample collected in microliters (µL)
Measured: Baseline (Day -7) to Day 90
Change in Fecal sIgA
Stool sample collected
Measured: Baseline (Day -7) to Day 90
Change in Fecal Calprotectin
Stool sample collected
Measured: Baseline (Day -7) to Day 90
Change in Fecal Alpha-1 Antitrypsin (AAT)
Stool sample collected
Measured: Baseline (Day -7) to Day 90
Change in Gut Microbiome Composition (Metagenomics)
Stool sample collected for metagenomic sequencing
Measured: Baseline (Day -7) to Day 90
Change in Fecal Metabolome (Non-targeted Metabolomics)
Stool sample collected for metabolomic analysis
Measured: Baseline (Day -7) to Day 90
Change in IGSQ Score
Questionnaire administered by site staff
Measured: Baseline (Day -7) to Day 90
Change in Stool Consistency (Brussels Infant Stool Hardness Scale)
Questionnaire administered by site staff
Measured: Baseline (Day -7) to Day 90
Change in TSAS Score
Questionnaire administered by site staff
Measured: Baseline (Day -7) to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start27 May 2026
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant GrowthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biostime (Changsha) Nutrition Foods Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534735
- Sponsor's protocol ID
- PFNF-2026-001
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth, Gut Health, Immune Function, and Sleep Status in Infants and Young Children Fed With Novel Infant Formula : A Randomized Trial
- ClinicalTrials.gov ID
- NCT07534735
- Acronym / sponsor ID
- PFNF-2026-001
- Conditions
- Infant Growth
- Keywords
- Human Milk Oligosaccharides, Infant Formula, Infant Growth, Gut Health, Immune Function, Sleep, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Biostime (Changsha) Nutrition Foods LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen University
- Study start
- 27 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Apr 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.
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Formula 1 | Experimental | Dietary Supplement: Investigational Formula 1 |
| Investigational Formula 2 | Experimental | Dietary Supplement: Investigational Formula 2 |
| Control: Commercial Infant Formula or Dairy Products | No intervention | – |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy full-term infants (gestational age 37-42 weeks).
- Age 12-18 months (inclusive).
- Weight below the 75th percentile according to the "Growth Reference Standards for Chinese Children Under 7 Years Old".
- Has started or plans to start stage 3 formula feeding before enrollment.
- Guardian voluntarily signs written informed consent and is able to comply with all study procedures including regular visits, intervention plan, and laboratory tests.
Key exclusion criteria (8 listed)
- Known allergy to milk protein or the study formula.
- Known allergic constitution or high allergy risk (parent with allergic constitution).
- Malnutrition assessed by investigator.
- Chronic infectious disease, metabolic disease, genetic disease, or any other condition affecting feeding or growth and development.
- History of preterm birth or admission to Neonatal Intensive Care Unit (NICU), excluding phototherapy for jaundice.
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 |
|---|---|---|
| Investigational Formula 1The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals | Dietary supplement | Investigational Formula 1 |
| Investigational Formula 2The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals | Dietary supplement | Investigational Formula 2 |
Primary outcome
Change in Height
Time frame: Baseline (Day -7) to Day 90
Measured in centimeters (cm)
Change in Weight
Time frame: Baseline (Day -7) to Day 90
Measured in kilograms (kg)
Comprehensive Nutritional Development Assessment
Time frame: Baseline (Day -7) to Day 90
(1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ).
10 secondary outcomes
Change in Salivary sIgA
Time frame: Baseline (Day -7) to Day 90
Change in Salivary Lysozyme
Time frame: Baseline (Day -7) to Day 90
Change in Fecal sIgA
Time frame: Baseline (Day -7) to Day 90
Change in Fecal Calprotectin
Time frame: Baseline (Day -7) to Day 90
Change in Fecal Alpha-1 Antitrypsin (AAT)
Time frame: Baseline (Day -7) to Day 90
Change in Gut Microbiome Composition (Metagenomics)
Time frame: Baseline (Day -7) to Day 90
Change in Fecal Metabolome (Non-targeted Metabolomics)
Time frame: Baseline (Day -7) to Day 90
Change in IGSQ Score
Time frame: Baseline (Day -7) to Day 90
Change in Stool Consistency (Brussels Infant Stool Hardness Scale)
Time frame: Baseline (Day -7) to Day 90
Change in TSAS Score
Time frame: Baseline (Day -7) to Day 90
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Formula 1 and Investigational Formula 2 in people with Infant Growth, run by Biostime (Changsha) Nutrition Foods Limited 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 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: looking for participants now, as of the sponsor's last update on 16 Jun 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?
Contact Pantian Huang (+86 13430375474, umi.huang@hh.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Height (time frame: Baseline (Day -7) to Day 90). 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 16 Jun 2026.