<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004729</url>
  </required_header>
  <id_info>
    <org_study_id>16.05.CLI</org_study_id>
    <nct_id>NCT03004729</nct_id>
  </id_info>
  <brief_title>Symptoms Based Awareness Confirmation Study - CoMiSS Validation</brief_title>
  <acronym>MOSAIC</acronym>
  <official_title>Symptoms Based Awareness Confirmation Study - CoMiSS Validation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to&#xD;
      recognize cow's milk related symptoms in infants and young children.&#xD;
&#xD;
      Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's&#xD;
      milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.&#xD;
&#xD;
      The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and&#xD;
      investigate if the CoMiSS tool could be an alternative to the open challenge test needed to&#xD;
      confirm the diagnosis of Cow Milk Protein Allergy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.</measure>
    <time_frame>baseline, Week 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>CoMiSS and component scores</measure>
    <time_frame>baseline, Week 2, Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family history of atopy</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Method of delivery at birth</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume intake of Alfamino formula every day</measure>
    <time_frame>baseline, week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's assessment of the likelihood that a subject has CMPA</measure>
    <time_frame>baseline, week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The result of Oral food Challenge (OFC)</measure>
    <time_frame>week 2, Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to elimination diet</measure>
    <time_frame>week 2</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Cow Milk Allergy</condition>
  <arm_group>
    <arm_group_label>CoMiSS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CoMiSS questionnaire</intervention_name>
    <arm_group_label>CoMiSS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female infant aged up to 6 months old&#xD;
&#xD;
          -  Has been fed exclusively on cow's milk infant formula for at least one week&#xD;
&#xD;
          -  Has CMPA symptoms that have been present for at least one week, and that developed&#xD;
             within the first two months of starting cow's milk infant formula&#xD;
&#xD;
          -  In the opinion of the investigator, requires a two week elimination diet with Amino&#xD;
             Acid Formula (AAF).&#xD;
&#xD;
          -  Had a gestational age at birth of 37 to 42 weeks&#xD;
&#xD;
          -  Had a birthweight of 2500 g to 4500 g&#xD;
&#xD;
          -  Informed consent signed by both parents, liable parent or legal guardian (if&#xD;
             applicable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has ever received either an extensively hydrolysed infant formula or an AAF prior to&#xD;
             enrolment&#xD;
&#xD;
          -  Has a fever above 38.5°C at enrolment&#xD;
&#xD;
          -  Has ever experienced a medically diagnosed serious anaphylactic reaction&#xD;
&#xD;
          -  Use of antibiotic drugs at enrolment. Infants may be enrolled if antibiotics have been&#xD;
             stopped at least 7 days prior to enrolment. (Antibiotic treatment can be initiated&#xD;
             during the study if an infant develops a condition after enrolment that requires&#xD;
             antibiotic treatment).&#xD;
&#xD;
          -  Infant with a health condition or family situation that makes the infant unsuitable to&#xD;
             participate in the trial according to the opinion of the investigator&#xD;
&#xD;
          -  Infant or infant's carers are unable to comply with trial procedures&#xD;
&#xD;
          -  Currently participating or has participated in another clinical trial within 4 weeks&#xD;
             prior to trial start.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhengyan Zhao, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Children's Hospital Zhejiang University School of Medicine (ZUCH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Fuzhou in Fujian province</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's hospital of Zhengzhou</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Children's Hospital</name>
      <address>
        <city>Hunan</city>
        <state>Hunan</state>
        <zip>410007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Shanghai</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200062</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's hospital of Shanxi Women health center of Shanxi</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternal and child health care hospital of guangdong province</name>
      <address>
        <city>Guangzhou</city>
        <zip>511400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Host A. Cow's milk protein allergy and intolerance in infancy. Some clinical, epidemiological and immunological aspects. Pediatr Allergy Immunol. 1994;5(5 Suppl):1-36.</citation>
    <PMID>7704117</PMID>
  </reference>
  <reference>
    <citation>Sampson HA. Food allergy. Part 1: immunopathogenesis and clinical disorders. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):717-28. doi: 10.1016/s0091-6749(99)70411-2.</citation>
    <PMID>10329801</PMID>
  </reference>
  <reference>
    <citation>Bock SA. Prospective appraisal of complaints of adverse reactions to foods in children during the first 3 years of life. Pediatrics. 1987 May;79(5):683-8.</citation>
    <PMID>3575022</PMID>
  </reference>
  <reference>
    <citation>Host A, Halken S. A prospective study of cow milk allergy in Danish infants during the first 3 years of life. Clinical course in relation to clinical and immunological type of hypersensitivity reaction. Allergy. 1990 Nov;45(8):587-96. doi: 10.1111/j.1398-9995.1990.tb00944.x.</citation>
    <PMID>2288394</PMID>
  </reference>
  <reference>
    <citation>Schrander JJ, van den Bogart JP, Forget PP, Schrander-Stumpel CT, Kuijten RH, Kester AD. Cow's milk protein intolerance in infants under 1 year of age: a prospective epidemiological study. Eur J Pediatr. 1993 Aug;152(8):640-4. doi: 10.1007/BF01955238.</citation>
    <PMID>8404966</PMID>
  </reference>
  <reference>
    <citation>Vandenplas Y; Althera Study Group; Steenhout P, Grathwohl D. A pilot study on the application of a symptom-based score for the diagnosis of cow's milk protein allergy. SAGE Open Med. 2014 Feb 13;2:2050312114523423. doi: 10.1177/2050312114523423. eCollection 2014.</citation>
    <PMID>26770708</PMID>
  </reference>
  <reference>
    <citation>Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.</citation>
    <PMID>23837862</PMID>
  </reference>
  <reference>
    <citation>Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015 Apr;104(4):334-9. doi: 10.1111/apa.12902. Epub 2015 Jan 29.</citation>
    <PMID>25557474</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>August 17, 2018</last_update_submitted>
  <last_update_submitted_qc>August 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergy</keyword>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Immunoglobulin E (IgE)</keyword>
  <keyword>CMPA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Milk Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004729
org study id: 16.05.CLI
nct id: NCT03004729
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: 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
measure: CoMiSS and component scores
time frame: baseline, Week 2, Week 4
measure: Family history of atopy
time frame: baseline
measure: Method of delivery at birth
time frame: baseline
measure: Anthropometric measurements
time frame: baseline
measure: Volume intake of Alfamino formula every day
time frame: baseline, week 2
measure: Physician's assessment of the likelihood that a subject has CMPA
time frame: baseline, week 2
measure: The result of Oral food Challenge (OFC)
time frame: week 2, Week 4
measure: Compliance to elimination diet
time frame: week 2
arm group label: CoMiSS
arm group type: Other
description: Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.
intervention type: Other
intervention name: CoMiSS questionnaire
arm group label: CoMiSS
criteria: 
gender: All
minimum age: 1 Day
maximum age: 6 Months
healthy volunteers: No
last name: Zhengyan Zhao, Prof
role: Principal Investigator
affiliation: The Children's Hospital Zhejiang University School of Medicine (ZUCH)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
citation: Host A. Cow's milk protein allergy and intolerance in infancy. Some clinical, epidemiological and immunological aspects. Pediatr Allergy Immunol. 1994;5(5 Suppl):1-36.
PMID: 7704117
citation: Sampson HA. Food allergy. Part 1: immunopathogenesis and clinical disorders. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):717-28. doi: 10.1016/s0091-6749(99)70411-2.
PMID: 10329801
citation: Bock SA. Prospective appraisal of complaints of adverse reactions to foods in children during the first 3 years of life. Pediatrics. 1987 May;79(5):683-8.
PMID: 3575022
citation: Host A, Halken S. A prospective study of cow milk allergy in Danish infants during the first 3 years of life. Clinical course in relation to clinical and immunological type of hypersensitivity reaction. Allergy. 1990 Nov;45(8):587-96. doi: 10.1111/j.1398-9995.1990.tb00944.x.
PMID: 2288394
citation: Schrander JJ, van den Bogart JP, Forget PP, Schrander-Stumpel CT, Kuijten RH, Kester AD. Cow's milk protein intolerance in infants under 1 year of age: a prospective epidemiological study. Eur J Pediatr. 1993 Aug;152(8):640-4. doi: 10.1007/BF01955238.
PMID: 8404966
citation: Vandenplas Y; Althera Study Group; Steenhout P, Grathwohl D. A pilot study on the application of a symptom-based score for the diagnosis of cow's milk protein allergy. SAGE Open Med. 2014 Feb 13;2:2050312114523423. doi: 10.1177/2050312114523423. eCollection 2014.
PMID: 26770708
citation: Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.
PMID: 23837862
citation: Vandenplas Y, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninckx C, Shah N, Shamir R, Staiano A, Szajewska H, Von Berg A. A workshop report on the development of the Cow's Milk-related Symptom Score awareness tool for young children. Acta Paediatr. 2015 Apr;104(4):334-9. doi: 10.1111/apa.12902. Epub 2015 Jan 29.
PMID: 25557474
responsible party type: Sponsor
mesh term: Milk Hypersensitivity
sharing ipd: No