A2 GUM Post-Market Effectiveness Study

Nestlé

Status

Completed

Conditions

Protein Intolerance

Treatments

Dietary Supplement: Toddler milk

Study type

Interventional

Funder types

Industry

Identifiers

NCT03698058

18.14.INF

Details and patient eligibility

About

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

Full 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.

Enrollment

387 patients

Sex

All

Ages

12 to 36 months old

Volunteers

Accepts Healthy Volunteers

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.