Isomil Post Marketing Observational Study

Melva Louisa

Status: Completed

Conditions: Cow's Milk Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT01809951

ANID-1101

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

534 participants in 1 patient group

Isomil Advance with LCP

Description:

4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day