Efficacy of Two HMOs in Chinese Infants

NCT06361719 | Recruiting

• 1 other identifier: 2312INF
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.

Conditions

Healthy Infants

Keywords

Human Milk Oligosaccharides; Infant gut microbiota; Infant gut health; Immune response; Growth; Tolerance

Outcome Measures

Primary Outcomes (1)

• Bifidobacteria abundance in fecal samples

  Bifidobacteria abundance using qPCR technology

  just prior to 3 months of age

Secondary Outcomes (25)

• Gut microbiota composition

  From enrollment until 12 months of age

• Fecal metabolism

  From enrollment until 12 months of age

• Fecal metabolism

  From enrollment until 12 months of age

• Fecal markers of intestinal immune health

  From enrollment until 6 months of age

• Fecal markers of gut barrier function

  From enrollment until 6 months of age

Other Outcomes (3)

• Formula feeding

  From enrollment until 12 months of age

• Breastfeeding

  From enrollment until 12 months of age

• Infant dietary pattern

  From 6 months of age until 12 months of age

Study Arms (3)

Experimental Group (EG)

EXPERIMENTAL

Starter infant formula supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula).

Other: Experimental Group (EG)

Control Group (CG)

ACTIVE COMPARATOR

Starter infant formula not supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula).

Other: Control Group (CG)

Breastfed Group (BG)

NO INTERVENTION

Breast Milk

Interventions

Experimental Group (EG) OTHER

Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).

Experimental Group (EG)

Control Group (CG) OTHER

Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).

Control Group (CG)

Eligibility Criteria

• Age: 3 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
• Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
• Infants whose parent(s) have reached the legal age of majority in China.
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
• Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
• Infants whose parent(s)/LAR have a working freezer.
• Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has 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 the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.

You may not qualify if:

• Infants with conditions requiring infant feedings other than those specified in the protocol.
• Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.
• Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected 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 investigator, would make the infant inappropriate for entry into the trial.
• Infants who are presently receiving or have received prior to enrolment probiotic supplements or any of the following: 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 microbiota (e.g., oral and 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 clinical trial since birth.
• Infant who has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

The International Peace Maternity & Child Health Hospital of China Welfare Institute

Shanghai, China

RECRUITING

Related Publications (1)

• Wang Y, Le Roy CI, Li J, Han S, Liu Z, Lahiry A, Sahu H, Li Q, Dong J, Mondragon A, Samuel TM, Cai W. Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 31;14:e66489. doi: 10.2196/66489.

  PMID: 41172301 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Wei Cai, MD

  Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiaoji Li

CONTACT

008613910051543; qiaoji.li@rd.nestle.com

Joyce Li

CONTACT

008615810125435; Joyce.Li@rd.nestle.com

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: April 8, 2024
• First Posted: April 12, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (1)