Evaluating the effects of two human milk oligosaccharides in healthy Chinese infants
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
This study is testing whether two types of human milk sugars can help healthy infants grow better and support their gut health compared to breastfed babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 3 Days to 14 Days |
| Sex | All |
| Sponsor | Société des Produits Nestlé (SPN) Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06361719 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled, double-blind intervention involves healthy male and female term infants to assess how two types of human milk oligosaccharides (HMOs) can positively influence gut microbiota, gut maturation, gut barrier integrity, immune response, and overall developmental outcomes. The study includes two groups of formula-fed infants receiving different HMOs and a non-randomized group of breastfed infants for comparison. The trial aims to provide insights into the role of HMOs in infant health and development.
Who should consider this trial
Good fit: Ideal candidates are healthy male and female infants aged 3-14 days who are either formula-fed or breastfed.
Not a fit: Infants with underlying health conditions or those not meeting the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance infant gut health and immune response, leading to better growth and development outcomes.
How similar studies have performed: Previous studies have shown promising results with HMOs in modulating gut health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established) 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.
Where this trial is running
Shanghai
- The International Peace Maternity & Child Health Hospital of China Welfare Institute — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Wei Cai, MD — Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Study coordinator: Qiaoji Li
- Email: qiaoji.li@rd.nestle.com
- Phone: 008613910051543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.