A2 GUM Post-Market Effectiveness Study

NCT ID: NCT03698058

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2019-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Protein Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A2 Growing Up Milk

Group Type EXPERIMENTAL

Toddler milk

Intervention Type DIETARY_SUPPLEMENT

Commercially available toddler milk

Traditional non-A2 milk

Group Type NO_INTERVENTION

No interventions assigned to this group

Other Growing Up Milk

Group Type ACTIVE_COMPARATOR

Toddler milk

Intervention Type DIETARY_SUPPLEMENT

Commercially available toddler milk

Interventions

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Toddler milk

Commercially available toddler milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Reproductive and Child Health, Peking University

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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18.14.INF

Identifier Type: -

Identifier Source: org_study_id

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