The Trial of a New Infant Formula in Healthy Term Chinese Infants

NCT06053112 | Active Not Recruiting

• 1 other identifier: JLB-CH002
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.

Conditions

Healthy Infants

Keywords

infant formula; HMOs

Outcome Measures

Primary Outcomes (1)

• Weight gain (g/day) between enrollment and the age of 4 months

  until the age of 4 months

Secondary Outcomes (16)

• Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values

  until the age of 4 months

• Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively

  until the age of 12 months

• Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively

  until the age of 12 months

• Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively

  until the age of 12 months

• Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively

  until the age of 12 months

Other Outcomes (4)

• Faecal markers of immune health and gut inflammation and barrier integrity at baseline, the age of 4 months, 6 months and 12 months respectively

  until the age of 12 months

• Illnesses and infections based on standard AE/SAE reporting

  until the age of 12 months

• Medication use based on standard AE/SAE reporting

  until the age of 12 months

Study Arms (3)

Test group

EXPERIMENTAL

New infant formula with 6 HMOs blend

Other: New infant formula with 6 HMOs blend

Control group

ACTIVE COMPARATOR

Standard infant formula without 6 HMOs blend

Other: Standard infant formula without 6 HMOs blend

Reference group

NO INTERVENTION

Breastfeeding

Interventions

New infant formula with 6 HMOs blend OTHER

Infants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.

Test group

Standard infant formula without 6 HMOs blend OTHER

Infants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.

Control group

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Parents/LAR(s) of infants have reached the legal age of majority in China.
• 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.
• At enrollment visit, infant post-natal age is ≤14 days (date of birth = day 0)
• Healthy term infant (≥37 weeks of gestation).
• Infant birth weight was ≥2500g and ≤4000g.
• 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.
• 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.

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 malformations (e.g., cleft palate, extremity malformation).
• Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
• 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.
• Currently participating or having participated in another interventional clinical trial since birth.

Sponsors & Collaborators

• Junlebao Dairy Group Co., Ltd.: lead
• Merieux NutriSciences (China): collaborator

Study Sites (5)

Affiliated Hospital of Jining Medical College

Jining, China

Location

Shanghai Public Health Clinical Center affiliated to Fudan University

Shanghai, China

Location

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

The Third People's Hospital affiliated to Hebei Medical University

Shijiazhuang, China

Location

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Study Officials

• Wei CAI, MD, Ph.D.

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

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

Model Details: Test group: infant formula with 6 HMOs blend; Control group: infant formula without 6 HMOs blends

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: September 25, 2023
• Study Start: November 12, 2023
• Primary Completion: May 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)