Healthy Term InfantNCT06686433
The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth
A study testing Novel infant formula and Standard infant formula in people with Healthy Term Infant, run by Biostime (Guangzhou) Health Products Limited at 5 sites in China.
Trial summary
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months. Read more about this study
- Who is it for?
- Ages Up to 42 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infant
- What is being tested?
- Novel infant formula and Standard infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 5 sitesChina
- Study dates
- 13 Jan 2025to 17 Aug 2026
- 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 Up to 42 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
- Healthy term infant (≥ 37 weeks of gestation).
- Infants birth weight ≥ 2500 and ≤ 4500 g.
- For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
- For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
- Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
- Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.
Who cannot join
- Conditions requiring infant feedings other than those specified in the protocol.
- Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Evidence of major congenital malformation (e.g., cleft palate, extremity malformation)
- Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
- Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.
- Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:
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- Fat digestion, absorption, and/or metabolism (e.g. pancreatic enzymes);
- Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
- Growth (e.g., insulin or growth hormone);
- Gastric acid secretion.
- Currently participating or having participated in another interventional clinical trial since birth.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Foshan Maternal and Child Health Hospital
Foshan
Guangzhou Women and Children's Medical Center
Guangzhou
Shenzhen Hospital of Southern Medical University
Shenzhen
Shenzhen Integrated Traditional Chinese and Western Medicine Hospital
Shenzhen
Zhongshan Boai Hospital
Zhongshan
About this study
Official title: Assessing the Impact of a Novel Infant Formula on Immunity, Gut Health and Safety: A Multicenter, Double-blind, Randomized, Controlled Trial
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
- Conditions
- Healthy Term Infant
- Being tested
- Novel infant formula, Standard infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel infant formulaOther
Infants are fed with the novel infant formula from the date of enrollment to the age of 6 months.
Standard infant formulaOther
Infants are fed with the standard infant formula from the date of enrollment to the age of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Novel infant formula Receives: Other: Novel infant formula |
| Control | Active comparator | Standard infant formula Receives: Other: Standard infant formula |
| Reference | No intervention | Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily body weight gain between V1 and V3
Measured: From baseline to the age of 6 months
Fecal total pathogens load
Measured: From baseline to the age of 6 months
Secondary outcomes (10)
Secretory IgA, calprotectin and antitrypsin A1 in feces at V1, V2 and V3
Measured: From baseline to the age of 3 months and the age of 6 months
sIgA in saliva at V1, V2 and V3
Measured: From baseline to the age of 3 months and the age of 6 months
Incidence of allergic disease reported by caregivers
Measured: From baseline to the age of 3 months and the age of 6 months
Incidence of infectious disease reported by caregivers
Measured: from baseline to the age of 3 months and the age of 6 months
Incidence of medications use reported by caregivers
Measured: From baseline to the age of 3 months and the age of 6 months
Additional anthropometric measures (body length and head circumference)
Measured: From baseline to the age of 3 months and the age of 6 months
GI symptoms and GI-related behaviors assessed via Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Measured: From baseline to the age of 3 months and the age of 6 months
Stooling patterns assessed via Amsterdam Infant Stool Scale (AISS)
Measured: From baseline to the age of 3 months and the age of 6 months
Overall composition of the fecal microbiota
Measured: From baseline to the age of 3 months and the age of 6 months
Fecal metabolome profiles
Measured: From baseline to the age of 3 months and the age of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start13 Jan 2025
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Term InfantStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biostime (Guangzhou) Health Products Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merieux NutriSciences (China), BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686433
- Sponsor's protocol ID
- Pistar2RCT
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2024
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Novel Infant Formula on Immunity, Gut Health and Safety: A Multicenter, Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06686433
- Acronym / sponsor ID
- Pistar2RCT
- Conditions
- Healthy Term Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Biostime (Guangzhou) Health Products LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Merieux NutriSciences (China), BioFortis
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 13 Nov 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.
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Other: Novel infant formulaNovel infant formula |
| Control | Active comparator | Other: Standard infant formulaStandard infant formula |
| Reference | No intervention | –Breastfeeding |
Who may qualify
- Ages
- Up to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
- Healthy term infant (≥ 37 weeks of gestation).
- Infants birth weight ≥ 2500 and ≤ 4500 g.
- For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
- For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
Key exclusion criteria (11 listed)
- Conditions requiring infant feedings other than those specified in the protocol.
- Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:
- Currently participating or having participated in another interventional clinical trial since birth.
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 |
|---|---|---|
| Novel infant formulaInfants are fed with the novel infant formula from the date of enrollment to the age of 6 months. | Other | Test |
| Standard infant formulaInfants are fed with the standard infant formula from the date of enrollment to the age of 6 months. | Other | Control |
Primary outcome
Daily body weight gain between V1 and V3
Time frame: From baseline to the age of 6 months
Fecal total pathogens load
Time frame: From baseline to the age of 6 months
10 secondary outcomes
Secretory IgA, calprotectin and antitrypsin A1 in feces at V1, V2 and V3
Time frame: From baseline to the age of 3 months and the age of 6 months
sIgA in saliva at V1, V2 and V3
Time frame: From baseline to the age of 3 months and the age of 6 months
Incidence of allergic disease reported by caregivers
Time frame: From baseline to the age of 3 months and the age of 6 months
Incidence of infectious disease reported by caregivers
Time frame: from baseline to the age of 3 months and the age of 6 months
Incidence of medications use reported by caregivers
Time frame: From baseline to the age of 3 months and the age of 6 months
Additional anthropometric measures (body length and head circumference)
Time frame: From baseline to the age of 3 months and the age of 6 months
GI symptoms and GI-related behaviors assessed via Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Time frame: From baseline to the age of 3 months and the age of 6 months
Stooling patterns assessed via Amsterdam Infant Stool Scale (AISS)
Time frame: From baseline to the age of 3 months and the age of 6 months
Overall composition of the fecal microbiota
Time frame: From baseline to the age of 3 months and the age of 6 months
Fecal metabolome profiles
Time frame: From baseline to the age of 3 months and the age of 6 months
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 27 Aug 2026.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel infant formula and Standard infant formula in people with Healthy Term Infant, run by Biostime (Guangzhou) Health Products Limited at 5 sites 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 7 inclusion and 11 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Daily body weight gain between V1 and V3 (time frame: From baseline to the age of 6 months). The study lists 2 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 27 Aug 2026.