Clinical trial NCT06361719: Efficacy of Two HMOs in Chinese Infants
Official title: Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Infants
Keywords: Human Milk Oligosaccharides
Infant gut microbiota
Infant gut health
Immune response
Growth
Tolerance
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 262
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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 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.

Primary outcomes:
measure: Bifidobacteria abundance in fecal samples
timeFrame: just prior to 3 months of age
Secondary outcomes:
measure: Gut microbiota composition
timeFrame: From enrollment until 12 months of age
measure: Fecal metabolism
timeFrame: From enrollment until 12 months of age
measure: Fecal metabolism
timeFrame: From enrollment until 12 months of age
measure: Fecal markers of intestinal immune health
timeFrame: From enrollment until 6 months of age
measure: Fecal markers of gut barrier function
timeFrame: From enrollment until 6 months of age
measure: Fecal markers of gut barrier function
timeFrame: From enrollment until 6 months of age
measure: Fecal markers of gut barrier function
timeFrame: From enrollment until 6 months of age
measure: Fecal markers of inflammation
timeFrame: From enrollment until 6 months of age
measure: Fecal markers of inflammation
timeFrame: From enrollment until 6 months of age
measure: Fecal markers of inflammation
timeFrame: From enrollment until 6 months of age
measure: Stool patterns
timeFrame: From enrollment until 14 days
measure: Stool patterns
timeFrame: From enrollment until 12 months of age
measure: GI symptoms and behaviors
timeFrame: From enrollment until 6 months of age
measure: Immune competence
timeFrame: From enrollment until 12 months of age
measure: Infant sleep duration and night-time wakings per 24 hours
timeFrame: From enrollment until 6 months of age
measure: Infant Health Related Quality of Life
timeFrame: From enrollment until 6 months of age
measure: Growth
timeFrame: From enrollment until 12 months of age
measure: Growth
timeFrame: From enrollment until 12 months of age
measure: Growth
timeFrame: From enrollment until 12 months of age
measure: Growth
timeFrame: From enrollment until 12 months of age
measure: Growth
timeFrame: From enrollment until 12 months of age
measure: Physical Examination
timeFrame: At enrollment and at 12 months of age
measure: Infant Illness
timeFrame: From enrollment until 12 months of age
measure: Infant illness, infections and medication usage
timeFrame: From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age
measure: Medication use (type and duration)
timeFrame: From enrollment until 12 months of age
Other outcomes:
measure: Formula feeding
timeFrame: From enrollment until 12 months of age
measure: Breastfeeding
timeFrame: From enrollment until 12 months of age
measure: Infant dietary pattern
timeFrame: From 6 months of age until 12 months of age
Locations:
city: Shanghai
country: China
facility: The International Peace Maternity & Child Health Hospital of China Welfare Institute
Study officials:
affiliation: Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Wei Cai, MD
role: PRINCIPAL_INVESTIGATOR
References: