Isomil Post Marketing Observational Study

A Prospective, Open-label, Post-marketing Observational Study to Document the Use of Soy-based Infant Formula With Low Chain Polyunsaturates (LCP) in Infants With Symptoms Suggestive to Cow's Milk Allergy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01809951

Enrollment

534

Registered

2013-03-13

Start date

2011-08-31

Completion date

2013-07-31

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Allergy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Months

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
percentage of infants with gastrointestinal adverse events	4-week
percentage of infants with adverse events	4-week

Countries

Indonesia

Outcome results