The Trial of a New Infant Formula in Healthy Term Chinese Infants
NCT ID: NCT06053112
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
326 participants
INTERVENTIONAL
2023-11-12
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Test group
New infant formula with 6 HMOs blend
New infant formula with 6 HMOs blend
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.
Control group
Standard infant formula without 6 HMOs blend
Standard infant formula without 6 HMOs blend
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.
Reference group
Breastfeeding
No interventions assigned to this group
Interventions
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New infant formula with 6 HMOs blend
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 blend
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.
Eligibility Criteria
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Inclusion Criteria
2. Parents/LAR(s) of infants have reached the legal age of majority in China.
3. 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.
4. At enrollment visit, infant post-natal age is ≤14 days (date of birth = day 0)
5. Healthy term infant (≥37 weeks of gestation).
6. Infant birth weight was ≥2500g and ≤4000g.
7. 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.
8. 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.
Exclusion Criteria
2. 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.
3. 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.
4. Currently participating or having participated in another interventional clinical trial since birth.
14 Days
ALL
Yes
Sponsors
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Merieux NutriSciences (China)
UNKNOWN
Junlebao Dairy Group Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei CAI, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Affiliated Hospital of Jining Medical College
Jining, , China
Shanghai Public Health Clinical Center affiliated to Fudan University
Shanghai, , China
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The Third People's Hospital affiliated to Hebei Medical University
Shijiazhuang, , China
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, , China
Countries
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Central Contacts
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Other Identifiers
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JLB-CH002
Identifier Type: -
Identifier Source: org_study_id
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