A2 GUM Post-Market Effectiveness Study

Protein Intolerance Clinical Trial

Official title:

Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698058
• Other study ID #: 18.14.INF
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: March 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Protein Intolerance

Intervention

Dietary Supplement:
• Toddler milk
Commercially available toddler milk

Locations

Country	Name	City	State
China	Institute of Reproductive and Child Health, Peking University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall digestive comfort	Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).	Baseline to Study Day 14
Secondary	Stool frequency	Stool frequency reported by parents in 3-Day GI Symptoms Diary	Baseline, Study Day 7, Study Day 14
Secondary	Stool consistency	Stool consistency score reported by parents in 3-Day GI Symptoms Diary	Baseline, Study Day 7, Study Day 14
Secondary	Consumption of other milk products	Reported by parents on 3 consecutive days on Milk Intake Diary	Baseline, Study Day 7, Study Day 14
Secondary	Child weight	Weight as measured by study staff in health clinic	Baseline, Study Day 7, Study Day 14
Secondary	Child height	Weight as measured by study staff in health clinic	Baseline, Study Day 7, Study Day 14
Secondary	Child head circumference	Head circumference as measured by study staff in health clinic	Baseline, Study Day 7, Study Day 14
Secondary	Adverse events	All adverse events reported by parents and confirmed by study investigator	Baseline to Study Day 14