search
Back to results

Symptoms Based Awareness Confirmation Study - CoMiSS Validation (MOSAIC)

Primary Purpose

Cow Milk Allergy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CoMiSS questionnaire
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cow Milk Allergy focused on measuring Allergy, Atopic Dermatitis, Immunoglobulin E (IgE), CMPA

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third Hospital
  • Children's Hospital of Chongqing Medical University
  • Children's Hospital of Fuzhou in Fujian province
  • The Second Affiliated Hospital of Harbin Medical University
  • Children's hospital of Zhengzhou
  • Hunan Children's Hospital
  • Children's Hospital of Shanghai
  • Children's hospital of Shanxi Women health center of Shanxi
  • The Children's Hospital Zhejiang University School of Medicine
  • Maternal and child health care hospital of guangdong province

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CoMiSS

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CoMiSS and component scores
Family history of atopy
Method of delivery at birth
Anthropometric measurements
Volume intake of Alfamino formula every day
Physician's assessment of the likelihood that a subject has CMPA
The result of Oral food Challenge (OFC)
Compliance to elimination diet

Full Information

First Posted
November 24, 2016
Last Updated
August 17, 2018
Sponsor
Société des Produits Nestlé (SPN)
search

1. Study Identification

Unique Protocol Identification Number
NCT03004729
Brief Title
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Acronym
MOSAIC
Official Title
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy
Keywords
Allergy, Atopic Dermatitis, Immunoglobulin E (IgE), CMPA

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoMiSS
Arm Type
Other
Arm Description
Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.
Intervention Type
Other
Intervention Name(s)
CoMiSS questionnaire
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
CoMiSS and component scores
Time Frame
baseline, Week 2, Week 4
Title
Family history of atopy
Time Frame
baseline
Title
Method of delivery at birth
Time Frame
baseline
Title
Anthropometric measurements
Time Frame
baseline
Title
Volume intake of Alfamino formula every day
Time Frame
baseline, week 2
Title
Physician's assessment of the likelihood that a subject has CMPA
Time Frame
baseline, week 2
Title
The result of Oral food Challenge (OFC)
Time Frame
week 2, Week 4
Title
Compliance to elimination diet
Time Frame
week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengyan Zhao, Prof
Organizational Affiliation
The Children's Hospital Zhejiang University School of Medicine (ZUCH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Facility Name
Children's Hospital of Fuzhou in Fujian province
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Children's hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450017
Country
China
Facility Name
Hunan Children's Hospital
City
Hunan
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Name
Children's Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Children's hospital of Shanxi Women health center of Shanxi
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Facility Name
The Children's Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Maternal and child health care hospital of guangdong province
City
Guangzhou
ZIP/Postal Code
511400
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7704117
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.
Results Reference
background
PubMed Identifier
10329801
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.
Results Reference
background
PubMed Identifier
3575022
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.
Results Reference
background
PubMed Identifier
2288394
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.
Results Reference
background
PubMed Identifier
8404966
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.
Results Reference
background
PubMed Identifier
26770708
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.
Results Reference
background
PubMed Identifier
23837862
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.
Results Reference
background
PubMed Identifier
25557474
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.
Results Reference
background
PubMed Identifier
35177461
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.
Results Reference
derived
PubMed Identifier
29773698
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.
Results Reference
derived

Learn more about this trial

Symptoms Based Awareness Confirmation Study - CoMiSS Validation

We'll reach out to this number within 24 hrs