Symptoms Based Awareness Confirmation Study - CoMiSS Validation

Cow Milk Allergy Clinical Trial

— MOSAIC  

Official title:

Symptoms Based Awareness Confirmation Study - CoMiSS Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004729
• Other study ID #: 16.05.CLI
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow Milk Allergy
• Milk Hypersensitivity

Intervention

Other:
• CoMiSS questionnaire

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Children's Hospital of Fuzhou in Fujian province	Fuzhou	Fujian
China	Maternal and child health care hospital of guangdong province	Guangzhou
China	The Second Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	The Children's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Hunan Children's Hospital	Hunan	Hunan
China	Children's Hospital of Shanghai	Shanghai	Shanghai
China	Children's hospital of Shanxi Women health center of Shanxi	Taiyuan	Shanxi
China	Children's hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

Høst 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. — View Citation

Høst 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. Review. — View Citation

Sampson HA. Food allergy. Part 1: immunopathogenesis and clinical disorders. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):717-28. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CoMiSS and component scores		baseline, Week 2, Week 4
Secondary	Family history of atopy		baseline
Secondary	Method of delivery at birth		baseline
Secondary	Anthropometric measurements		baseline
Secondary	Volume intake of Alfamino formula every day		baseline, week 2
Secondary	Physician's assessment of the likelihood that a subject has CMPA		baseline, week 2
Secondary	The result of Oral food Challenge (OFC)		week 2, Week 4
Secondary	Compliance to elimination diet		week 2