Status:
COMPLETED
Isomil Post Marketing Observational Study
Lead Sponsor:
Melva Louisa
Conditions:
Cow's Milk Allergy
Eligibility:
All Genders
6-12 years
Brief Summary
The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine...
Eligibility Criteria
Inclusion
- infants of 6 - 12 months of age
- full term infants
- birth weight more than 2500 grams
- infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements
- subject is prescribed a soy-based infant formula by physician
Exclusion
- established/suspected hypersensitivity fo soy
- presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease
- history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases
- presence of severe gastrointestinal disorder
- subject is participating in any interventional clinical study
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT01809951
Start Date
August 1 2011
End Date
July 1 2013
Last Update
June 16 2017
Active Locations (1)
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1
Divisi Alergi Imunologi FKUI RSCM
Jakarta, Indonesia, 10430