Clinical trial NCT03698058: A2 GUM Post-Market Effectiveness Study
Official title: Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Intolerance
Keywords: Nutrition
Toddlers
A2
B-casein
Gut comfort
Growing up milk
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-10-05
Enrollment: 387
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.

Detailed description: This post-market study primarily aims to assess the real-life effectiveness of a newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and GI-related behaviors compared with other milk products and milk alternatives.

Eligibility criteria: Inclusion Criteria:

* Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
* Children 12 - 36 months of age at enrolment.
* Children who have been born full-term (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
* Children who are habitually consuming some cow's milk, other traditional milks (including non-A2 GUMs, kids' milk, white milk, flavored milk) and/or dairy or non-dairy alternative milks (such as those sourced from goats, sheep, soy, rice, coconut, and nut).
* Child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures.
* Known and diagnosed cow's milk protein allergy.
* Children currently using or having ever used specialty infant formula and/or GUMs such as hypoallergenic (HA), lactose-free, or anti-regurgitation formulas.
* Children who have known cognitive and developmental disorders.

Primary outcomes:
measure: Overall digestive comfort
timeFrame: Baseline to Study Day 14
Secondary outcomes:
measure: Stool frequency
timeFrame: Baseline, Study Day 7, Study Day 14
measure: Stool consistency
timeFrame: Baseline, Study Day 7, Study Day 14
measure: Consumption of other milk products
timeFrame: Baseline, Study Day 7, Study Day 14
measure: Child weight
timeFrame: Baseline, Study Day 7, Study Day 14
measure: Child height
timeFrame: Baseline, Study Day 7, Study Day 14
measure: Child head circumference
timeFrame: Baseline, Study Day 7, Study Day 14
measure: Adverse events
timeFrame: Baseline to Study Day 14
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Reproductive and Child Health, Peking University
Study officials:
References: