Healthy InfantsHexaHMONCT06053112
The Trial of a New Infant Formula in Healthy Term Chinese Infants
A study testing New infant formula with 6 HMOs blend and Standard infant formula without 6 HMOs blend in people with Healthy Infants, run by Junlebao Dairy Group Co., Ltd. at 5 sites in China.
Trial summary
The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- New infant formula with 6 HMOs blend and Standard infant formula without 6 HMOs blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 5 sitesChina
- Study dates
- 12 Nov 2023to 21 May 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Evidence of personally signed and dated informed consent indicating that the infant's both parents/legally acceptable representative(s) (LAR(s)), as per local regulation, have been informed of all pertinent aspects of the study.
- Parents/LAR(s) of infants have reached the legal age of majority in China.
- Parents/LAR(s) of infants are willing and able to comply with scheduled visits, and the requirements of the study protocol and can be contacted directly by telephone throughout the study.
- At enrollment visit, infant post-natal age is ≤14 days (date of birth = day 0)
- Healthy term infant (≥37 weeks of gestation).
- Infant birth weight was ≥2500g and ≤4000g.
- For formula-fed groups, infant is exclusively consuming and tolerating a cow' s milk infant formula since at least 3 days prior to enrollment. Its parents/LAR(s) have 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 its parents/LAR(s) have made the decision to continue exclusively breastfeeding until at least 4 months of age.
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 malformations (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 infant inappropriate for entry into the study. Of note, infants who are normally healthy but at the time of enrollment suffering from acute illness in a minor condition which are common in infancy and do not require some of the exclusionary medication mentioned below can be enrolled.
- Presently receiving or have received prior to enrollment any 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 gut microbiota (e.g., oral, or 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 interventional clinical trial since birth.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Affiliated Hospital of Jining Medical College
Jining
Shanghai Public Health Clinical Center affiliated to Fudan University
Shanghai
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
The Third People's Hospital affiliated to Hebei Medical University
Shijiazhuang
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
About this study
Official title: Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial
The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.
- Conditions
- Healthy Infants
- Being tested
- New infant formula with 6 HMOs blend, Standard infant formula without 6 HMOs blend
- Keywords
- infant formula, HMOs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New infant formula with 6 HMOs blendOther
Infants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.
Standard infant formula without 6 HMOs blendOther
Infants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | New infant formula with 6 HMOs blend Receives: Other: New infant formula with 6 HMOs blend |
| Control group | Active comparator | Standard infant formula without 6 HMOs blend Receives: Other: Standard infant formula without 6 HMOs blend |
| Reference group | No intervention | Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain (g/day) between enrollment and the age of 4 months
Measured: until the age of 4 months
Secondary outcomes (16)
Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values
Measured: until the age of 4 months
Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Head circumference gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Head-circumference-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively
Measured: until the age of 12 months
Stool pattern, GI symptoms and GI-related behaviors recorded in the retrospective 1-day questionnaire at baseline and in the prospective 3-day GI Symptom and Behavior Diary for 3 days prior to the age of 42 days, 3 months, 4 months, 6 months
Measured: until the age of 6 months
Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Fecal acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, isovaleric acid, and total short chain fatty acids at baseline, the age of 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively
Measured: until the age of 12 months
Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values
Measured: until 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 posted25 Sep 2023
- Study start12 Nov 2023
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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
- Model description
- Test group: infant formula with 6 HMOs blend; Control group: infant formula without 6 HMOs blends
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junlebao Dairy Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merieux NutriSciences (China)
- Responsible party
- Sponsor
- Investigators
- Wei CAI, MD, Ph.D., Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053112
- Sponsor's protocol ID
- JLB-CH002
- Acronym
- HexaHMO
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2023
- 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
- Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06053112
- Acronym / sponsor ID
- HexaHMO / JLB-CH002
- Conditions
- Healthy Infants
- Keywords
- infant formula, HMOs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Junlebao Dairy Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merieux NutriSciences (China)
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 25 Sep 2023 (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 aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Test group: infant formula with 6 HMOs blend; Control group: infant formula without 6 HMOs blends
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: New infant formula with 6 HMOs blendNew infant formula with 6 HMOs blend |
| Control group | Active comparator | Other: Standard infant formula without 6 HMOs blendStandard infant formula without 6 HMOs blend |
| Reference group | No intervention | –Breastfeeding |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Evidence of personally signed and dated informed consent indicating that the infant's both parents/legally acceptable representative(s) (LAR(s)), as per local regulation, have been informed of all pertinent aspects of the study.
- Parents/LAR(s) of infants have reached the legal age of majority in China.
- Parents/LAR(s) of infants are willing and able to comply with scheduled visits, and the requirements of the study protocol and can be contacted directly by telephone throughout the study.
- At enrollment visit, infant post-natal age is ≤14 days (date of birth = day 0)
- Healthy term infant (≥37 weeks of gestation).
Key exclusion criteria (7 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 have received prior to enrollment any 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 gut microbiota (e.g., oral, or 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 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 |
|---|---|---|
| New infant formula with 6 HMOs blendInfants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months. | Other | Test group |
| Standard infant formula without 6 HMOs blendInfants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months. | Other | Control group |
Primary outcome
Weight gain (g/day) between enrollment and the age of 4 months
Time frame: until the age of 4 months
16 secondary outcomes
Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values
Time frame: until the age of 4 months
Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Head circumference gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Head-circumference-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively
Time frame: until the age of 12 months
Stool pattern, GI symptoms and GI-related behaviors recorded in the retrospective 1-day questionnaire at baseline and in the prospective 3-day GI Symptom and Behavior Diary for 3 days prior to the age of 42 days, 3 months, 4 months, 6 months
Time frame: until the age of 6 months
Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Fecal acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, isovaleric acid, and total short chain fatty acids at baseline, the age of 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively
Time frame: until the age of 12 months
Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values
Time frame: until 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.
Wei CAI, MD, Ph.D. principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New infant formula with 6 HMOs blend and Standard infant formula without 6 HMOs blend in people with Healthy Infants, run by Junlebao Dairy Group Co., Ltd. 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 8 inclusion and 7 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?
Weight gain (g/day) between enrollment and the age of 4 months (time frame: until the age of 4 months). 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.