Efficacy of Two HMOs in Chinese Infants

NCT ID: NCT06361719

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group (EG)

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

Group Type: EXPERIMENTAL

Experimental Group (EG)

Intervention Type: 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)

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).

Group Type: ACTIVE_COMPARATOR

Control Group (CG)

Intervention Type: 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).

Breastfed Group (BG)

Breast Milk

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental Group (EG)

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).

Intervention Type: OTHER

Control Group (CG)

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Cai, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiaoji Li

Role: CONTACT

qiaoji.li@rd.nestle.com

008613910051543

Joyce Li

Role: CONTACT

Joyce.Li@rd.nestle.com

008615810125435

Facility Contacts

Zhiwei Liu

Role: primary

References

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.

Reference Type: DERIVED

PMID: 41172301 (View on PubMed)

Other Identifiers

2312INF

Identifier Type: -

Identifier Source: org_study_id