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

NCT06686433 | Active Not Recruiting

• 1 other identifier: Pistar2RCT
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 5

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.

Conditions

Healthy Term Infant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Other Outcomes (1)

• The breast milk composition

  At baseline only

Study Arms (3)

Test

EXPERIMENTAL

Novel infant formula

Other: Novel infant formula

Control

ACTIVE COMPARATOR

Standard infant formula

Other: Standard infant formula

Reference

NO INTERVENTION

Breastfeeding

Interventions

Standard infant formula OTHER

Infants are fed with the standard infant formula from the date of enrollment to the age of 6 months.

Control

Novel infant formula OTHER

Infants are fed with the novel infant formula from the date of enrollment to the age of 6 months.

Test

Eligibility Criteria

• Age: Up to 42 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• Currently participating or having participated in another interventional clinical trial since birth.

Sponsors & Collaborators

• Biostime (Guangzhou) Health Products Limited: lead
• Merieux NutriSciences (China): collaborator
• BioFortis: collaborator

Study Sites (5)

Foshan Maternal and Child Health Hospital

Foshan, China

Location

Guangzhou Women and Children's Medical Center

Guangzhou, China

Location

Shenzhen Hospital of Southern Medical University

Shenzhen, China

Location

Shenzhen Integrated Traditional Chinese and Western Medicine Hospital

Shenzhen, China

Location

Zhongshan Boai Hospital

Zhongshan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 13, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)