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
1 other identifier
observational
534
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 25, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 16, 2017
June 1, 2017
1.7 years
January 25, 2013
June 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
percentage of infants with gastrointestinal adverse events
4-week
percentage of infants with adverse events
4-week
Study Arms (1)
Isomil Advance with LCP
4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day
Eligibility Criteria
Infants with symptoms suggestive adverse reactions to cow's milk protein
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melva Louisalead
Study Sites (1)
Divisi Alergi Imunologi FKUI RSCM
Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 25, 2013
First Posted
March 13, 2013
Study Start
August 1, 2011
Primary Completion
April 1, 2013
Study Completion
July 1, 2013
Last Updated
June 16, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share