Symptoms Based Awareness Confirmation Study - CoMiSS Validation

NCT03004729 | Completed

• 1 other identifier: 16.05.CLI
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

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.

Conditions

Cow Milk Allergy

Keywords

Allergy; Atopic Dermatitis; Immunoglobulin E (IgE); CMPA

Outcome Measures

Primary Outcomes (1)

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

  baseline, Week 2

Secondary Outcomes (8)

• CoMiSS and component scores

  baseline, Week 2, Week 4

• Family history of atopy

  baseline

• Method of delivery at birth

  baseline

• Anthropometric measurements

  baseline

• Volume intake of Alfamino formula every day

  baseline, week 2

Study Arms (1)

CoMiSS

OTHER

Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.

Other: CoMiSS questionnaire

Interventions

CoMiSS questionnaire OTHER

CoMiSS

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (10)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

Children's Hospital of Fuzhou in Fujian province

Fuzhou, Fujian, 350005, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Children's hospital of Zhengzhou

Zhengzhou, Henan, 450017, China

Location

Hunan Children's Hospital

Hunan, Hunan, 410007, China

Location

Children's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200062, China

Location

Children's hospital of Shanxi Women health center of Shanxi

Taiyuan, Shanxi, 030013, China

Location

The Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Maternal and child health care hospital of guangdong province

Guangzhou, 511400, China

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35177461 DERIVED

• 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.

  PMID: 29773698 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity; Hypersensitivity; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Zhengyan Zhao, Prof

  The Children's Hospital Zhejiang University School of Medicine (ZUCH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 29, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)