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AzTrials

Cow Milk AllergyMOSAICNCT03004729

Symptoms Based Awareness Confirmation Study - CoMiSS Validation

A study testing CoMiSS questionnaire in people with Cow Milk Allergy, run by Société des Produits Nestlé (SPN) at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 day to 6 months
Conditions the study is for
Cow Milk Allergy
What is being tested?
CoMiSS questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
10 sitesChina
Study dates
Dec 2016to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

  • Children's Hospital of Fuzhou in Fujian province

    Fuzhou, Fujian, 350005

  • Maternal and child health care hospital of guangdong province

    Guangzhou, 511400

  • The Children's Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Hunan Children's Hospital

    Hunan, Hunan, 410007

  • Children's Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200062

  • Children's hospital of Shanxi Women health center of Shanxi

    Taiyuan, Shanxi, 030013

  • Children's hospital of Zhengzhou

    Zhengzhou, Henan, 450017

Other trials in China

About this study

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.

Being tested
CoMiSS questionnaire
Keywords
Allergy, Atopic Dermatitis, Immunoglobulin E (IgE), CMPA
Medical subject headings
Milk Hypersensitivity, Hypersensitivity, Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CoMiSS questionnaireOther

Study groups in NCT03004729
Study groupRoleWhat they receive
CoMiSSOtherMeasure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.
Receives: Other: CoMiSS questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.

    Measured: baseline, Week 2

Secondary outcomes (8)

  1. CoMiSS and component scores

    Measured: baseline, Week 2, Week 4

  2. Family history of atopy

    Measured: baseline

  3. Method of delivery at birth

    Measured: baseline

  4. Anthropometric measurements

    Measured: baseline

  5. Volume intake of Alfamino formula every day

    Measured: baseline, week 2

  6. Physician's assessment of the likelihood that a subject has CMPA

    Measured: baseline, week 2

  7. The result of Oral food Challenge (OFC)

    Measured: week 2, Week 4

  8. Compliance to elimination diet

    Measured: week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJan 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03004729
Sponsor's protocol ID
16.05.CLI
Acronym
MOSAIC
Status last verified
Aug 2018
First submitted
24 Nov 2016
Last updated
20 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 7704117

  • 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.

    PubMed 10329801

  • 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.

    PubMed 3575022

  • 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.

    PubMed 2288394

  • 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.

    PubMed 8404966

  • 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.

    PubMed 26770708

  • 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.

    PubMed 23837862

  • 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.

    PubMed 25557474

  • Vandenplas Y, Zhao ZY, Mukherjee R, Dupont C, Eigenmann P, Kuitunen M, Ribes Koninckx C, Szajewska H, von Berg A, Bajerova K, Meyer R, Salvatore S, Shamir R, Jarvi A, Heine RG; MOSAIC Study Investigator Group. Assessment of the Cow's Milk-related Symptom Score (CoMiSS) as a diagnostic tool for cow's milk protein allergy: a prospective, multicentre study in China (MOSAIC study). BMJ Open. 2022 Feb 17;12(2):e056641. doi: 10.1136/bmjopen-2021-056641.

    PubMed 35177461

  • Vandenplas Y, Mukherjee R, Dupont C, Eigenmann P, Host A, Kuitunen M, Ribes-Koninkx C, Shah N, Szajewska H, von Berg A, Heine RG, Zhao ZY; on behalf the Chinese CoMiSS Investigator Team.. Protocol for the validation of sensitivity and specificity of the Cow's Milk-related Symptom Score (CoMiSS) against open food challenge in a single-blinded, prospective, multicentre trial in infants. BMJ Open. 2018 May 17;8(5):e019968. doi: 10.1136/bmjopen-2017-019968.

    PubMed 29773698

Questions about this trial

What is this clinical trial studying?

A study testing CoMiSS questionnaire in people with Cow Milk Allergy, run by Société des Produits Nestlé (SPN) at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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. (time frame: baseline, Week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03004729, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.

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