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

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 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.

Study Overview

• Status: Completed
• Conditions: Healthy Children
• Intervention / Treatment: Dietary supplement: Goat-milk Based Formula

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formula fed; Goat-milk Based Formula (Stage 3)	Dietary supplement: Goat-milk Based Formula; Provided Goat-milk Based Formula for babies 1-2 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool characteristics	Stool characteristics assessed with BITSS	before and 7, 14, 21 and 28 days after administration of the investigational product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptoms	Gastrointestinal symptoms assessed with Gastrointestinal Symptom Questionnaire	before and 7, 14, 21 and 28 days after administration of the investigational product
Quality of life of subjects	Quality of life of subjects assessed with Pediatric Quality of Life Inventory (PedsQL)	before and 28 days after administration of the investigational product
Lifestyle-related immune indicators	Lifestyle-related immunity status reported by parents or medically diagnosed (indicated in the subject's medical file)	before and 28 days after administration of the investigational product

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators.	Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators.	screening until 4 weeks after product intervention

Collaborators and Investigators

• Sponsor: Danone Nutricia
• Investigators: Principal Investigator: Zailing Li, PhD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NELN202212A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No