Isomil Post Marketing Observational Study

Melva Louisa534 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

534

Conditions

Cow's Milk Allergy

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (1)

Divisi Alergi Imunologi FKUI RSCM

Jakarta, Indonesia

Outcomes

Primary Outcomes

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

Time frame: 4-week

Secondary Outcomes

percentage of infants with gastrointestinal adverse events

Time frame: 4-week

percentage of infants with adverse events

Time frame: 4-week

Data from ClinicalTrials.gov

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