CompletedNot Applicable

Isomil Post Marketing Observational Study

Indonesia534 participantsStarted 2011-08

Plain-language 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.

Who can participate

Age range6 Months – 12 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 4-week

Trial details

NCT IDNCT01809951

SponsorMelva Louisa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Cow's Milk Allergy trials