COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Isomil Post Marketing Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01809951
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : June 16, 2017
Information provided by (Responsible Party):
Melva Louisa, Indonesia University

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.

Condition or disease
Cow's Milk Allergy

Layout table for study information
Study Type : Observational
Actual Enrollment : 534 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : August 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 [ Time Frame: 4-week ]

Secondary Outcome Measures :
  1. percentage of infants with gastrointestinal adverse events [ Time Frame: 4-week ]
  2. percentage of infants with adverse events [ Time Frame: 4-week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with symptoms suggestive adverse reactions to cow's milk protein

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01809951

Layout table for location information
Divisi Alergi Imunologi FKUI RSCM
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Melva Louisa
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Melva Louisa, PhD, Indonesia University Identifier: NCT01809951    
Other Study ID Numbers: ANID-1101
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate