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Symptoms Based Awareness Confirmation Study - CoMiSS Validation (MOSAIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03004729
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Other: CoMiSS questionnaire Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03004729

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nestlé Identifier: NCT03004729    
Other Study ID Numbers: 16.05.CLI
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nestlé:
Atopic Dermatitis
Immunoglobulin E (IgE)
Additional relevant MeSH terms:
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Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate