The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Term Infant
• Intervention / Treatment: Other: Novel infant formula; Other: Standard infant formula

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Foshan, China
    • Foshan Maternal and Child Health Hospital
  • Guangzhou, China
    • Guangzhou Women and Children's Medical Center
  • Shenzhen, China
    • Shenzhen Hospital of Southern Medical University
  • Shenzhen, China
    • Shenzhen Integrated Traditional Chinese and Western Medicine Hospital
  • Zhongshan, China
    • Zhongshan Boai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Novel infant formula	Other: Novel infant formula; Infants are fed with the novel infant formula from the date of enrollment to the age of 6 months.
Active Comparator: Control; Standard infant formula	Other: Standard infant formula; Infants are fed with the standard infant formula from the date of enrollment to the age of 6 months.
No Intervention: Reference; Breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Daily body weight gain between V1 and V3	From baseline to the age of 6 months
Fecal total pathogens load	From baseline to the age of 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
The breast milk composition	At baseline only

Collaborators and Investigators

• Sponsor: Biostime (Guangzhou) Health Products Limited
• Collaborators: BioFortis; Merieux NutriSciences (China)

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pistar2RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No