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

Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Infants
• Intervention / Treatment: Other: New infant formula with 6 HMOs blend; Other: Standard infant formula without 6 HMOs blend

• Study Type: Interventional
• Enrollment (Estimated): 326
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yiping XUN, Ph.D.; Phone Number: +86-15630401019; Email: xunyiping@jlbry.com

Study Locations

• China
  • Changsha, China
    • Not yet recruiting
    • The Second Xiangya Hospital Of Central South University
  • Shanghai, China
    • Recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai, China
    • Recruiting
    • Shanghai Public Health Clinical Center affiliated to Fudan University
  • Shijiazhuang, China
    • Not yet recruiting
    • The Third People's Hospital affiliated to Hebei Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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.
2. Parents/LAR(s) of infants have reached the legal age of majority in China.
3. 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.
4. At enrollment visit, infant post-natal age is ≤14 days (date of birth = day 0)
5. Healthy term infant (≥37 weeks of gestation).
6. Infant birth weight was ≥2500g and ≤4000g.
7. 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.
8. 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.

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:

   • 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).
   • Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infant inappropriate for entry into the study. Of note, infants who are normally healthy but at the time of enrollment suffering from acute illness in a minor condition which are common in infancy and do not require some of the exclusionary medication mentioned below can be enrolled.
3. 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.
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 group; New infant formula with 6 HMOs blend	Other: New infant formula with 6 HMOs blend; 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.
Active Comparator: Control group; Standard infant formula without 6 HMOs blend	Other: Standard infant formula without 6 HMOs blend; 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.
No Intervention: Reference group; Breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight gain (g/day) between enrollment and the age of 4 months	until the age of 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Head circumference 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
Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively	until the age of 12 months
Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively	until the age of 12 months
Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively	until the age of 12 months
Head-circumference-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively	until the age of 12 months
Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively	until the age of 12 months
Stool pattern, GI symptoms and GI-related behaviors recorded in the retrospective 1-day questionnaire at baseline and in the prospective 3-day GI Symptom and Behavior Diary for 3 days prior to the age of 42 days, 3 months, 4 months, 6 months	until the age of 6 months
Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively	until the age of 12 months
Fecal acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, isovaleric acid, and total short chain fatty acids at baseline, the age of 4 months, 6 months and 12 months respectively	until the age of 12 months
Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively	until the age of 12 months
Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values	until the age of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal markers of immune health and gut inflammation and barrier integrity at baseline, the age of 4 months, 6 months and 12 months respectively	calprotectin, α-1-antitrypsin, lipocalin-2, claudin-3, cathelicidin, α-defensin and β-defensin assessed by ELISA	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
Breastmilk composition assessed by HPLC at baseline, the age of 42 days, 4 months and 6 months respectively		until the age of 6 months

Collaborators and Investigators

• Sponsor: Junlebao Dairy Group Co., Ltd.
• Collaborators: Merieux NutriSciences (China)
• Investigators: Principal Investigator: Wei CAI, MD, Ph.D., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: infant formula; HMOs
• Other Study ID Numbers: JLB-CH002

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