Symptoms Based Awareness Confirmation Study - CoMiSS Validation
NCT ID: NCT03004729
Last Updated: 2018-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
300 participants
INTERVENTIONAL
2016-12-31
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy
NCT05883384
COMISS Score for Detection of Cow's Milk Protein Allergy in Children With Recrrent or Persistent Gastrointestinal Manifistations in Infants Attending Assuit University Children Hospital - Egypt
NCT03664076
Microbiome and Immune Profiling in Infant With Cow's Milk Allergy
NCT05178004
Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children
NCT04249973
Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University Children Hospital
NCT03456479
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CoMiSS
Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.
CoMiSS questionnaire
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CoMiSS questionnaire
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
1 Day
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhengyan Zhao, Prof
Role: PRINCIPAL_INVESTIGATOR
The Children's Hospital Zhejiang University School of Medicine (ZUCH)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Children's Hospital of Fuzhou in Fujian province
Fuzhou, Fujian, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Children's hospital of Zhengzhou
Zhengzhou, Henan, China
Hunan Children's Hospital
Hunan, Hunan, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Children's hospital of Shanxi Women health center of Shanxi
Taiyuan, Shanxi, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Maternal and child health care hospital of guangdong province
Guangzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16.05.CLI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.