Isomil Post Marketing Observational Study
Completed
- Conditions
- Cow's Milk Allergy
- Registration Number
- NCT01809951
- Lead Sponsor
- Melva Louisa
- 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 the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 534
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein 4-week
- Secondary Outcome Measures
Name Time Method percentage of infants with gastrointestinal adverse events 4-week percentage of infants with adverse events 4-week
Trial Locations
- Locations (1)
Divisi Alergi Imunologi FKUI RSCM
🇮🇩Jakarta, Indonesia