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

Biostime (Guangzhou) Health Products Limited5 sites in 1 country342 target enrollmentJanuary 13, 2025

ConditionsHealthy Term Infant

InterventionsNovel infant formula Standard infant formula

Overview

Phase: N/A
Intervention: Novel infant formula
Conditions: Healthy Term Infant
Sponsor: Biostime (Guangzhou) Health Products Limited
Enrollment: 342
Locations: 5
Primary Endpoint: Daily body weight gain between V1 and V3
Status: Active, Not Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.

Registry

clinicaltrials.gov

Start Date

January 13, 2025

End Date

December 1, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biostime (Guangzhou) Health Products Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
•Healthy term infant (≥ 37 weeks of gestation).
•Infants birth weight ≥ 2500 and ≤ 4500 g.
•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.
•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.
•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.
•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

•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 malformation (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 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.
•Presently receiving or having received prior to enrolment 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);
•Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
•Growth (e.g., insulin or growth hormone);
•Gastric acid secretion.

Arms & Interventions

Test

Novel infant formula

Intervention: Novel infant formula

Control

Standard infant formula

Intervention: Standard infant formula

Reference

Breastfeeding

Outcomes

Primary Outcomes

Daily body weight gain between V1 and V3

Time Frame: From baseline to the age of 6 months

Fecal total pathogens load

Time Frame: From baseline to the age of 6 months

Secondary Outcomes

Secretory IgA, calprotectin and antitrypsin A1 in feces at V1, V2 and V3(From baseline to the age of 3 months and the age of 6 months)
sIgA in saliva at V1, V2 and V3(From baseline to the age of 3 months and the age of 6 months)
Incidence of allergic disease reported by caregivers(From baseline to the age of 3 months and the age of 6 months)
Incidence of infectious disease reported by caregivers(from baseline to the age of 3 months and the age of 6 months)
Incidence of medications use reported by caregivers(From baseline to the age of 3 months and the age of 6 months)
Additional anthropometric measures (body length and head circumference)(From baseline to the age of 3 months and the age of 6 months)
GI symptoms and GI-related behaviors assessed via Infant Gastrointestinal Symptom Questionnaire (IGSQ)(From baseline to the age of 3 months and the age of 6 months)
Stooling patterns assessed via Amsterdam Infant Stool Scale (AISS)(From baseline to the age of 3 months and the age of 6 months)
Overall composition of the fecal microbiota(From baseline to the age of 3 months and the age of 6 months)
Fecal metabolome profiles(From baseline to the age of 3 months and the age of 6 months)