Exploring health benefits of goat milk formula for toddlers
An Exploratory Real-world Study to Explore the Effects of a Goat-milk Based Formula on Gut Health and Related Health Benefits in Healthy, Term-born Chinese Young Children
This study is testing if a goat milk formula can help improve the health of toddlers aged 1-2 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 1 Year to 2 Years |
| Sex | All |
| Sponsor | Danone Nutricia Industry-sponsored |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06287385 on ClinicalTrials.gov |
What this trial studies
This exploratory real-world study aims to investigate the health benefits of a goat milk-based formula for toddlers aged 1-2 years. The study will involve healthy term infants and will collect data on various health parameters to generate hypotheses regarding the product's effects. Participants will be required to use a secure WeChat platform for data collection, including recording stool and completing questionnaires. The focus is on understanding how this formula may contribute to the health of young children.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy toddlers aged 1-2 years from the Chinese population who are intended to be fed goat milk formula.
Not a fit: Patients who are not healthy or do not fall within the specified age range or population may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the health advantages of goat milk formula for toddlers, potentially influencing dietary choices for young children.
How similar studies have performed: While this study explores a relatively novel approach, similar studies on alternative milk formulas have shown varying degrees of success in understanding their health impacts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 1-2 years of age 2. Healthy term infants, gestational ages 37\~42 weeks 3. Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart); 4. Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart) 5. Chinese population; 6. Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period; 7. Informed consent from one parent or legal representative; 8. Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents; 9. Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires; 10. Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study. Exclusion Criteria: 1. Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment; 2. Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment; 3. Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.; 4. Known allergy to milk products or soy product; 5. Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc; 6. Significant congenital abnormality or other health conditions that could affect the outcome measurements; 7. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements; 8. Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
Where this trial is running
Beijing, Beijing
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Zailing Li, PhD — Peking University Third Hospital
- Study coordinator: peggy ge
- Email: peggy.ge@danone.com
- Phone: +13764082982
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.