Testing a new infant formula for healthy Chinese infants

Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial

This study is testing a new infant formula with special ingredients to see if it helps healthy Chinese infants grow better compared to a regular formula.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 326 (estimated)
• Ages: N/A to 14 Days
• Sex: All
• Sponsor: Junlebao Dairy Group Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Jining and 3 other locations)
• Trial ID: NCT06053112 on ClinicalTrials.gov

What this trial studies

This randomized, controlled, multi-center, double-blind trial aims to evaluate the safety and efficacy of a new infant formula containing a specific blend of six human milk oligosaccharides (HMOs) in healthy term infants. The study will compare the growth outcomes of infants receiving the experimental formula against those receiving a standard formula over a period of four months. Parents or legal representatives will provide informed consent, and infants will be monitored for their growth and health during the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy term infants aged 14 days or younger who are exclusively formula-fed and whose parents have chosen not to breastfeed.

Not a fit: Infants who are not healthy, preterm, or those who are exclusively breastfed may not benefit from this study.

Why it matters

Potential benefit: If successful, this new infant formula could provide enhanced nutritional benefits for healthy infants, potentially improving their growth and development.

How similar studies have performed: While similar studies have explored the benefits of HMOs in infant formulas, the specific combination and its effects in this population may be novel.

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.

Where this trial is running

Jining and 3 other locations

• Affiliated Hospital of Jining Medical College — Jining, China (Recruiting)
• Shanghai Public Health Clinical Center affiliated to Fudan University — Shanghai, China (Recruiting)
• Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• The Third People's Hospital affiliated to Hebei Medical University — Shijiazhuang, China (Recruiting)

Study contacts

• Principal investigator: Wei CAI, MD, Ph.D. — Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Yiping XUN, Ph.D.

Conditions Healthy Infants; infant formula; HMOs