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

Healthy Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287385
• Other study ID #: NELN202212A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: February 2024
• Source: Danone Nutricia
• Contact: peggy ge
• Phone: +13764082982
• Email: peggy.ge[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Children

Intervention

Dietary Supplement:
• Goat-milk Based Formula
Provided Goat-milk Based Formula for babies 1-2 years old

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Danone Nutricia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety parameters	Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators.	screening until 4 weeks after product intervention
Primary	Stool characteristics	Stool characteristics assessed with BITSS	before and 7, 14, 21 and 28 days after administration of the investigational product
Secondary	Gastrointestinal symptoms	Gastrointestinal symptoms assessed with Gastrointestinal Symptom Questionnaire	before and 7, 14, 21 and 28 days after administration of the investigational product
Secondary	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
Secondary	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