Assessing a new infant formula's effects on immunity and growth in healthy infants

Assessing the Impact of a Novel Infant Formula on Immunity, Gut Health and Safety: A Multicenter, Double-blind, Randomized, Controlled Trial

This study is testing a new infant formula to see if it helps healthy babies grow better and boosts their immune system compared to a standard formula.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: N/A to 42 Days
• Sex: All
• Sponsor: Biostime (Guangzhou) Health Products Limited (Industry-sponsored)
• Locations: 1 site (Shenzhen)
• Trial ID: NCT06686433 on ClinicalTrials.gov

What this trial studies

This multicenter, double-blind, randomized, controlled trial aims to evaluate the safety and efficacy of a novel infant formula in healthy term infants from enrollment until they reach 6 months of age. Participants will be divided into two groups: one receiving the new formula and the other receiving a standard infant formula. The study will monitor various health parameters, including immunity, gut health, and growth metrics, to determine the formula's impact. Parents or legal representatives must provide informed consent and ensure adherence to the study protocol.

Who should consider this trial

Good fit: Ideal candidates are healthy term infants aged 42 days or younger who are primarily formula-fed or breastfed.

Not a fit: Infants who are not healthy term infants or those who are exclusively breastfed and not eligible for formula intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved infant nutrition and health outcomes through enhanced formula options.

How similar studies have performed: While similar studies have explored infant nutrition, the specific approach of this novel formula is relatively untested.

Eligibility criteria

Inclusion Criteria:

1. At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
2. Healthy term infant (≥ 37 weeks of gestation).
3. Infants birth weight ≥ 2500 and ≤ 4500 g.
4. For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
5. For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
6. Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
7. Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.

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:

   1. Evidence of major congenital malformation (e.g., cleft palate, extremity malformation)
   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
   3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.
3. Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:

   1. Fat digestion, absorption, and/or metabolism (e.g. pancreatic enzymes);
   2. Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
   3. Growth (e.g., insulin or growth hormone);
   4. Gastric acid secretion.
4. Currently participating or having participated in another interventional clinical trial since birth.

Where this trial is running

Shenzhen

• Shenzhen Hospital of Southern Medical University — Shenzhen, China (Recruiting)

Conditions Healthy Term Infant