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

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 Overview

• Status: Completed
• Conditions: Cow's Milk Allergy

• Study Type: Observational
• Enrollment (Actual): 534

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Divisi Alergi Imunologi FKUI RSCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants with symptoms suggestive adverse reactions to cow's milk protein

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Isomil Advance with LCP; 4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Melva Louisa
• Investigators: Principal Investigator: Zakiudin Munasir, MD, PhD, Division of allergy and Immunology, Department of Child Health, Faculty of Medicine, Universitas Indonesia; Study Chair: Sumadiono, MD, PhD, RS Sardjito, Jl Kesehatan No 1 Yogyakarta; Study Chair: Anang Endaryanto, MD, PhD, Allergy Immunology Working Unit, East Java Branch of Indonesian Pediatric Society; Study Chair: Dina Muktiarti, MD, Sub Divisi Alergi Imunologi IKA FKUI, Jakarta; Study Chair: Dewi Kumara Wati, MD, PhD, RSUP Sanglah, Jl Kesehatan No 1-10 Denpasar Bali; Study Chair: Budi Setiabudiawan, MD, PhD, RS Hasan Sadikin Jl Pasteur No 38 Bandung

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: ANID-1101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO