Clinical trial NCT03004729: Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Official title: Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Keywords: Allergy
Atopic Dermatitis
Immunoglobulin E (IgE)
CMPA
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-12-29
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.
timeFrame: baseline, Week 2
Secondary outcomes:
measure: CoMiSS and component scores
timeFrame: baseline, Week 2, Week 4
measure: Family history of atopy
timeFrame: baseline
measure: Method of delivery at birth
timeFrame: baseline
measure: Anthropometric measurements
timeFrame: baseline
measure: Volume intake of Alfamino formula every day
timeFrame: baseline, week 2
measure: Physician's assessment of the likelihood that a subject has CMPA
timeFrame: baseline, week 2
measure: The result of Oral food Challenge (OFC)
timeFrame: week 2, Week 4
measure: Compliance to elimination diet
timeFrame: week 2
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Children's Hospital of Fuzhou in Fujian province
state: Fujian
city: Ha'erbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Children's hospital of Zhengzhou
state: Henan
city: Hunan
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
state: Shanghai
city: Taiyuan
country: China
facility: Children's hospital of Shanxi Women health center of Shanxi
state: Shanxi
city: Hangzhou
country: China
facility: The Children's Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Guangzhou
country: China
facility: Maternal and child health care hospital of guangdong province
Study officials:
affiliation: The Children's Hospital Zhejiang University School of Medicine (ZUCH)
name: Zhengyan Zhao, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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: 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: 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: 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.
citation: 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.