Clinical trial NCT06287385: An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Children
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Stool characteristics
timeFrame: before and 7, 14, 21 and 28 days after administration of the investigational product
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: before and 7, 14, 21 and 28 days after administration of the investigational product
measure: Quality of life of subjects
timeFrame: before and 28 days after administration of the investigational product
measure: Lifestyle-related immune indicators
timeFrame: before and 28 days after administration of the investigational product
Other outcomes:
measure: Safety assessment includes adverse events as reported spontaneously by parents or collected by investigators.
timeFrame: screening until 4 weeks after product intervention
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Zailing Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: