Actively Recruiting
Efficacy of Two HMOs in Chinese Infants
Led by Société des Produits Nestlé (SPN) · Updated on 2025-11-28
262
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Two HMOs in Chinese Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female infants aged 3 to 14 days at enrollment
- Signed informed consent from parent(s) or legal representative
- Parent(s) must be legally adults in China
- Parent(s)/legal representatives willing to follow study visits and protocol
- Parent(s)/legal representatives reachable by phone during the trial
- Parent(s)/legal representatives have a working freezer at home
- Singleton, healthy full-term birth (≥37 weeks gestation)
- Birth weight between 2.5 kg and 4.5 kg
- For formula-fed: exclusively fed and tolerating cow's milk formula for at least 3 days before enrollment; mother chose not to breastfeed
- For breastfed group: exclusively breastfed since birth (small amounts of other feedings only in first 3 days) with intention to continue exclusive breastfeeding for at least 3 months
You will not qualify if you...
- Infants needing feeding other than specified formula or breastfeeding
- Infants receiving 4 or more teaspoons (about 20 g) of complementary foods or liquids before enrollment
- Infants with major congenital malformations (e.g., cleft palate, limb malformations)
- Infants with documented or suspected infections like HIV, cytomegalovirus, or syphilis
- Infants with severe or ongoing medical or laboratory abnormalities
- Infants currently or previously given probiotics, antibiotics, or medications affecting fat digestion, stool, growth, or gastric acid
- Participation in another clinical trial since birth
- Known or suspected allergies or intolerance to cow's milk protein, lactose, or soy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The International Peace Maternity & Child Health Hospital of China Welfare Institute
Shanghai, China
Actively Recruiting
Research Team
Q
Qiaoji Li
CONTACT
J
Joyce Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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