Healthy InfantsNCT06361719
Efficacy of Two HMOs in Chinese Infants
A study testing Experimental Group (EG) in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. Read more about this study
- Who is it for?
- Ages 3 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Experimental Group (EG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2024to Jun 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 3 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
- Infants whose parent(s) have reached the legal age of majority in China.
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
- Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
- Infants whose parent(s)/LAR have a working freezer.
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- Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has independently elected not to breastfeed.
- For the breastfed reference group: infant has been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established) and the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.
Who cannot join
- Infants with conditions requiring infant feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.
- Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected 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 investigator, would make the infant inappropriate for entry into the trial.
- Infants who are presently receiving or have received prior to enrolment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and microbiota (e.g., oral and systemic antibiotics, glycerine 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 clinical trial since birth.
- Infant who has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy.
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
The International Peace Maternity & Child Health Hospital of China Welfare Institute
Shanghai
Zhiwei Liu
About this study
Official title: Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.
- Conditions
- Healthy Infants
- Being tested
- Experimental Group (EG), Control Group (CG)
- Keywords
- Human Milk Oligosaccharides, Infant gut microbiota, Infant gut health, Immune response, Growth, Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group (EG)Other
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
Control Group (CG)Other
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | Starter infant formula supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula). Receives: Other: Experimental Group (EG) |
| Control Group (CG) | Active comparator | Starter infant formula not supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula). Receives: Other: Control Group (CG) |
| Breastfed Group (BG) | No intervention | Breast Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifidobacteria abundance in fecal samples
Bifidobacteria abundance using qPCR technology
Measured: just prior to 3 months of age
Secondary outcomes (25)
Gut microbiota composition
Relative abundance of beneficial and potentially pathogenic species using next generation sequencing (NGS) technology
Measured: From enrollment until 12 months of age
Fecal metabolism
Fecal pH analyzed using HPLC as well as targeted or untargeted metabolomics profiling
Measured: From enrollment until 12 months of age
Fecal metabolism
Short chain fatty acids analyzed using HPLC as well as targeted or untargeted metabolomics profiling
Measured: From enrollment until 12 months of age
Fecal markers of intestinal immune health
Fecal secretory IgA measured by ELISA
Measured: From enrollment until 6 months of age
Fecal markers of gut barrier function
Calprotectin measured by ELISA
Measured: From enrollment until 6 months of age
Fecal markers of gut barrier function
α-1-antitrypsin measured by ELISA
Measured: From enrollment until 6 months of age
Fecal markers of gut barrier function
Lipocalin-2 measured by ELISA
Measured: From enrollment until 6 months of age
Fecal markers of inflammation
Levels of cytokines such as IL-1β measured by ELISA
Measured: From enrollment until 6 months of age
Fecal markers of inflammation
Levels of cytokines such as IFN-γ measured by ELISA
Measured: From enrollment until 6 months of age
Fecal markers of inflammation
Levels of cytokines such as TNF-α measured by ELISA
Measured: From enrollment until 6 months of age
Stool patterns
Stool frequency, consistency, and difficulty in passing stools assessed using a 1-day retrospective stool consistency diary (24-hr recall)
Measured: From enrollment until 14 days
Stool patterns
Stool frequency, consistency, and difficulty in passing stools assessed using a 3-day prospective collection recorded in the stool consistency diary.
Measured: From enrollment until 12 months of age
GI symptoms and behaviors
IGSQ-13 Questionnaire
Measured: From enrollment until 6 months of age
Immune competence
Pediatric Immune System Index score
Measured: From enrollment until 12 months of age
Infant sleep duration and night-time wakings per 24 hours
Brief infant sleep questionnaire (BISQ)
Measured: From enrollment until 6 months of age
Infant Health Related Quality of Life
Infant Toddler Quality of Life Questionnaire (ITQoL -SF47)
Measured: From enrollment until 6 months of age
Growth
Weight (g) and corresponding Z-scores
Measured: From enrollment until 12 months of age
Growth
Length (cm) and corresponding Z-scores
Measured: From enrollment until 12 months of age
Growth
Head circumference (cm) and corresponding Z-scores
Measured: From enrollment until 12 months of age
Growth
Weight gain and corresponding Z-scores
Measured: From enrollment until 12 months of age
Growth
Length gain, corresponding Z-scores
Measured: From enrollment until 12 months of age
Physical Examination
Measured: At enrollment and at 12 months of age
Infant Illness
Infant Illness Diary
Measured: From enrollment until 12 months of age
Infant illness, infections and medication usage
AEs and Serious Adverse Events (SAEs)
Measured: From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age
Medication use (type and duration)
Concomitant medication form and Infant Illness Diary
Measured: From enrollment until 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start29 Jul 2024
- Primary completionNov 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Cai, MD, Principal investigator, Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361719
- Sponsor's protocol ID
- 2312INF
- Status last verified
- Nov 2025
- First submitted
- 8 Apr 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Le Roy CI, Li J, Han S, Liu Z, Lahiry A, Sahu H, Li Q, Dong J, Mondragon A, Samuel TM, Cai W. Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 31;14:e66489. doi: 10.2196/66489.
PubMed 41172301
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group
- ClinicalTrials.gov ID
- NCT06361719
- Acronym / sponsor ID
- 2312INF
- Conditions
- Healthy Infants
- Keywords
- Human Milk Oligosaccharides, Infant gut microbiota, Infant gut health, Immune response, Growth, Tolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Apr 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 a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.
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 |
|---|---|---|
| Experimental Group (EG) | Experimental | Other: Experimental Group (EG)Starter infant formula supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula). |
| Control Group (CG) | Active comparator | Other: Control Group (CG)Starter infant formula not supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula). |
| Breastfed Group (BG) | No intervention | –Breast Milk |
Who may qualify
- Ages
- 3 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
- Infants whose parent(s) have reached the legal age of majority in China.
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
- Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
Key exclusion criteria (6 listed)
- Infants with conditions requiring infant feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.
- Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected 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 investigator, would make the infant inappropriate for entry into the trial.
- Infants who are presently receiving or have received prior to enrolment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and microbiota (e.g., oral and systemic antibiotics, glycerine 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 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 |
|---|---|---|
| Experimental Group (EG)Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age). | Other | Experimental Group (EG) |
| Control Group (CG)Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age). | Other | Control Group (CG) |
Primary outcome
Bifidobacteria abundance in fecal samples
Time frame: just prior to 3 months of age
Bifidobacteria abundance using qPCR technology
25 secondary outcomes
Gut microbiota composition
Time frame: From enrollment until 12 months of age
Fecal metabolism
Time frame: From enrollment until 12 months of age
Fecal metabolism
Time frame: From enrollment until 12 months of age
Fecal markers of intestinal immune health
Time frame: From enrollment until 6 months of age
Fecal markers of gut barrier function
Time frame: From enrollment until 6 months of age
Fecal markers of gut barrier function
Time frame: From enrollment until 6 months of age
Fecal markers of gut barrier function
Time frame: From enrollment until 6 months of age
Fecal markers of inflammation
Time frame: From enrollment until 6 months of age
Fecal markers of inflammation
Time frame: From enrollment until 6 months of age
Fecal markers of inflammation
Time frame: From enrollment until 6 months of age
Stool patterns
Time frame: From enrollment until 14 days
Stool patterns
Time frame: From enrollment until 12 months of age
GI symptoms and behaviors
Time frame: From enrollment until 6 months of age
Immune competence
Time frame: From enrollment until 12 months of age
Infant sleep duration and night-time wakings per 24 hours
Time frame: From enrollment until 6 months of age
Infant Health Related Quality of Life
Time frame: From enrollment until 6 months of age
Growth
Time frame: From enrollment until 12 months of age
Growth
Time frame: From enrollment until 12 months of age
Growth
Time frame: From enrollment until 12 months of age
Growth
Time frame: From enrollment until 12 months of age
Growth
Time frame: From enrollment until 12 months of age
Physical Examination
Time frame: At enrollment and at 12 months of age
Infant Illness
Time frame: From enrollment until 12 months of age
Infant illness, infections and medication usage
Time frame: From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age
Medication use (type and duration)
Time frame: From enrollment until 12 months of age
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 28 Nov 2025.
- Derived from this study: PubMed 41172301Wang Y, Le Roy CI, Li J, Han S, Liu Z, Lahiry A, Sahu H, Li Q, Dong J, Mondragon A, Samuel TM, Cai W. Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 31;14:e66489. doi: 10.2196/66489.
- 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.
Wei Cai, MD principal investigator
Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (EG) in people with Healthy Infants, 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 9 inclusion and 6 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 28 Nov 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?
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 Qiaoji Li (008613910051543, qiaoji.li@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bifidobacteria abundance in fecal samples (time frame: just prior to 3 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06361719, which also lists 1 linked publication.
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 28 Nov 2025.