Clinical trial NCT06053112: The Trial of a New Infant Formula in Healthy Term Chinese Infants
Official title: Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Infants
Keywords: infant formula
HMOs
Lead sponsor: Junlebao Dairy Group Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Merieux NutriSciences (China)
First posted: 2023-09-25
Enrollment: 326
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group: infant formula with 6 HMOs blend; Control group: infant formula without 6 HMOs blends
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight gain (g/day) between enrollment and the age of 4 months
timeFrame: until the age of 4 months
Secondary outcomes:
measure: Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values
timeFrame: until the age of 4 months
measure: Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Head circumference gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: 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
timeFrame: until the age of 12 months
measure: Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: 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
timeFrame: until the age of 6 months
measure: Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: 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
timeFrame: until the age of 12 months
measure: Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values
timeFrame: until the age of 6 months
Other outcomes:
measure: Faecal markers of immune health and gut inflammation and barrier integrity at baseline, the age of 4 months, 6 months and 12 months respectively
timeFrame: until the age of 12 months
measure: Illnesses and infections based on standard AE/SAE reporting
timeFrame: until the age of 12 months
measure: Medication use based on standard AE/SAE reporting
timeFrame: until the age of 12 months
measure: Breastmilk composition assessed by HPLC at baseline, the age of 42 days, 4 months and 6 months respectively
timeFrame: until the age of 6 months
Locations:
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center affiliated to Fudan University
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
city: Shijiazhuang
country: China
facility: The Third People's Hospital affiliated to Hebei Medical University
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Wei CAI, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: