Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03004729
Other study ID # 16.05.CLI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date July 2018

Study information

Verified date August 2018
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05943704 - The Frequency of Beef Allergy in Children With Cow Milk Allergy N/A
Completed NCT00874627 - Sublingual Milk Immunotherapy in Children N/A
Not yet recruiting NCT03664076 - 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
Not yet recruiting NCT04576845 - The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
Recruiting NCT05785299 - Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy N/A
Not yet recruiting NCT04327297 - Mineral Status Ininfants With Cow's Milk Protein Allergy
Completed NCT02351531 - Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy Phase 3
Recruiting NCT05064917 - BAT Cow's Milk for the Replacement of the Food Challenge Test
Recruiting NCT05406141 - Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy N/A
Recruiting NCT02087930 - Microbiota as Potential Target for Food Allergy
Completed NCT01940068 - A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates N/A
Completed NCT00664768 - A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy N/A
Recruiting NCT02785679 - The Influence of Early and Continuous Exposure of Infants to Cow's Milk Formula on the Prevention of Milk Allergy N/A
Recruiting NCT05618704 - Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula N/A
Not yet recruiting NCT03456479 - Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University Children Hospital N/A
Recruiting NCT03223181 - Assessment of Cow's Milk-related Symptom Scoring Awareness Tool in Young Turkish Children N/A
Completed NCT03236207 - Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula N/A
Active, not recruiting NCT03644381 - Milk Desensitization in Children N/A
Active, not recruiting NCT04249973 - Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children
Not yet recruiting NCT04684329 - Serum Esnophilic Cationic Protein Level as Diagnostic Marker in Cow Milk Protein Allergy Infants