An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits

NCT ID: NCT06287385

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2024-12-31

Brief Summary

This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.

Conditions

Healthy Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Formula fed

Goat-milk Based Formula (Stage 3)

Group Type: EXPERIMENTAL

Goat-milk Based Formula

Intervention Type: DIETARY_SUPPLEMENT

Provided Goat-milk Based Formula for babies 1-2 years old

Interventions

Goat-milk Based Formula

Provided Goat-milk Based Formula for babies 1-2 years old

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Nutricia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zailing Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NELN202212A

Identifier Type: -

Identifier Source: org_study_id