The Trial of a New Infant Formula in Healthy Term Chinese Infants

Launched by JUNLEBAO DAIRY GROUP CO., LTD. · Sep 19, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new infant formula designed for healthy term infants in China. The goal is to see if this new formula, which contains a special mix of six human milk sugars, is safe and effective for infants. The study will compare the growth of babies who are given the new formula with those who are given a standard formula. Infants will be monitored from the time they join the study until they reach 4 months of age.

To participate in the trial, infants need to be healthy, born at full term (after at least 37 weeks of pregnancy), and weigh between 5.5 pounds and 8.8 pounds at birth. Parents or legal guardians must also be available to attend scheduled visits and keep in contact with the study team. It’s important to note that breastfeeding infants are also included in the study, as long as they are exclusively fed breast milk. Participants will be closely observed, and their growth and health will be tracked throughout the study. If you think your baby might be eligible or if you have questions, please reach out to the study team for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 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:
• • 1. Conditions requiring infant feedings other than those specified in the protocol.
• 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.