A2 GUM Post-Market Effectiveness Study

NCT03698058 | Completed

• 1 other identifier: 18.14.INF
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Protein Intolerance

Keywords

Nutrition; Toddlers; A2; B-casein; Gut comfort; Growing up milk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Stool frequency

  Baseline, Study Day 7, Study Day 14

• Stool consistency

  Baseline, Study Day 7, Study Day 14

• Consumption of other milk products

  Baseline, Study Day 7, Study Day 14

• Child weight

  Baseline, Study Day 7, Study Day 14

• Child height

  Baseline, Study Day 7, Study Day 14

Study Arms (3)

A2 Growing Up Milk

EXPERIMENTAL

Dietary Supplement: Toddler milk

Traditional non-A2 milk

NO INTERVENTION

Other Growing Up Milk

ACTIVE COMPARATOR

Dietary Supplement: Toddler milk

Interventions

Toddler milk DIETARY_SUPPLEMENT

Commercially available toddler milk

A2 Growing Up Milk; Other Growing Up Milk

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Institute of Reproductive and Child Health, Peking University

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: September 15, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)