Symptoms Based Awareness Confirmation Study - CoMiSS Validation (MOSAIC)

August 17, 2018 updated by: Nestlé

The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children.

Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.

The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and investigate if the CoMiSS tool could be an alternative to the open challenge test needed to confirm the diagnosis of Cow Milk Protein Allergy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China, 511400
        • Maternal and child health care hospital of guangdong province
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Children's Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Children's Hospital of Fuzhou in Fujian province
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150001
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450017
        • Children's Hospital of Zhengzhou
    • Hunan
      • Hunan, Hunan, China, 410007
        • Hunan Children's Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200062
        • Children's Hospital of Shanghai
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Children's hospital of Shanxi Women health center of Shanxi
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The Children's Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female infant aged up to 6 months old
  • Has been fed exclusively on cow's milk infant formula for at least one week
  • Has CMPA symptoms that have been present for at least one week, and that developed within the first two months of starting cow's milk infant formula
  • In the opinion of the investigator, requires a two week elimination diet with Amino Acid Formula (AAF).
  • Had a gestational age at birth of 37 to 42 weeks
  • Had a birthweight of 2500 g to 4500 g
  • Informed consent signed by both parents, liable parent or legal guardian (if applicable).

Exclusion Criteria:

  • Has ever received either an extensively hydrolysed infant formula or an AAF prior to enrolment
  • Has a fever above 38.5°C at enrolment
  • Has ever experienced a medically diagnosed serious anaphylactic reaction
  • Use of antibiotic drugs at enrolment. Infants may be enrolled if antibiotics have been stopped at least 7 days prior to enrolment. (Antibiotic treatment can be initiated during the study if an infant develops a condition after enrolment that requires antibiotic treatment).
  • Infant with a health condition or family situation that makes the infant unsuitable to participate in the trial according to the opinion of the investigator
  • Infant or infant's carers are unable to comply with trial procedures
  • Currently participating or has participated in another clinical trial within 4 weeks prior to trial start.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CoMiSS
Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.
Other: CoMiSS questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.
Time Frame: baseline, Week 2
baseline, Week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
CoMiSS and component scores
Time Frame: baseline, Week 2, Week 4
baseline, Week 2, Week 4
Family history of atopy
Time Frame: baseline
baseline
Method of delivery at birth
Time Frame: baseline
baseline
Anthropometric measurements
Time Frame: baseline
baseline
Volume intake of Alfamino formula every day
Time Frame: baseline, week 2
baseline, week 2
Physician's assessment of the likelihood that a subject has CMPA
Time Frame: baseline, week 2
baseline, week 2
The result of Oral food Challenge (OFC)
Time Frame: week 2, Week 4
week 2, Week 4
Compliance to elimination diet
Time Frame: week 2
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Zhengyan Zhao, Prof, The Children's Hospital Zhejiang University School of Medicine (ZUCH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.05.CLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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