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

Junlebao Dairy Group Co., Ltd.8 sites in 1 country326 target enrollmentNovember 12, 2023

ConditionsHealthy Infants

InterventionsNew infant formula with 6 HMOs blend Standard infant formula without 6 HMOs blend

Overview

Phase: N/A
Intervention: New infant formula with 6 HMOs blend
Conditions: Healthy Infants
Sponsor: Junlebao Dairy Group Co., Ltd.
Enrollment: 326
Locations: 8
Primary Endpoint: Weight gain (g/day) between enrollment and the age of 4 months
Status: Active, Not Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 12, 2023

End Date

December 1, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Junlebao Dairy Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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).
•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.
•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.

Arms & Interventions

Test group

New infant formula with 6 HMOs blend

Intervention: New infant formula with 6 HMOs blend

Control group

Standard infant formula without 6 HMOs blend

Intervention: Standard infant formula without 6 HMOs blend

Reference group

Breastfeeding

Outcomes

Primary Outcomes

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

Time Frame: until the age of 4 months

Secondary Outcomes

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)
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)
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)
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)
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 pH at baseline, the age of 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)
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 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 secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values(until the age of 6 months)