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Completed

NCT Number: NCT03698058

A2 GUM Post-Market Effectiveness Study

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

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Key information

Conditions

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Reproductive and Child Health, Peking University

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toddler Milk

Dietary Supplement

Commercially available toddler milk

Primary outcomes

  1. Overall digestive comfort

    Time frame: Baseline to Study Day 14

    Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).

Secondary outcomes

  1. Stool frequency

    Time frame: Baseline, Study Day 7, Study Day 14

    Stool frequency reported by parents in 3-Day GI Symptoms Diary

  2. Stool consistency

    Time frame: Baseline, Study Day 7, Study Day 14

    Stool consistency score reported by parents in 3-Day GI Symptoms Diary

  3. Consumption of other milk products

    Time frame: Baseline, Study Day 7, Study Day 14

    Reported by parents on 3 consecutive days on Milk Intake Diary

  4. Child weight

    Time frame: Baseline, Study Day 7, Study Day 14

    Weight as measured by study staff in health clinic

  5. Child height

    Time frame: Baseline, Study Day 7, Study Day 14

    Weight as measured by study staff in health clinic

  6. Child head circumference

    Time frame: Baseline, Study Day 7, Study Day 14

    Head circumference as measured by study staff in health clinic

  7. Adverse events

    Time frame: Baseline to Study Day 14

    All adverse events reported by parents and confirmed by study investigator

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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