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Completed

NCT Number: NCT03004729

Symptoms Based Awareness Confirmation Study - CoMiSS Validation

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.

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Key information

Conditions

Cow Milk Allergy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Food Hypersensitivity Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CoMiSS questionnaire

Other

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.

    Time frame: baseline, Week 2

Secondary outcomes

  1. CoMiSS and component scores

    Time frame: baseline, Week 2, Week 4

  2. Family history of atopy

    Time frame: baseline

  3. Method of delivery at birth

    Time frame: baseline

  4. Anthropometric measurements

    Time frame: baseline

  5. Volume intake of Alfamino formula every day

    Time frame: baseline, week 2

  6. Physician's assessment of the likelihood that a subject has CMPA

    Time frame: baseline, week 2

  7. The result of Oral food Challenge (OFC)

    Time frame: week 2, Week 4

  8. Compliance to elimination diet

    Time frame: week 2

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Acronym: MOSAIC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2016
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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