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Isomil Post Marketing Observational Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01809951
First Posted: March 13, 2013
Last Update Posted: June 16, 2017
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.
Information provided by (Responsible Party):
Melva Louisa, Indonesia University
  Purpose
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
Cow's Milk Allergy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Melva Louisa, Indonesia University:

Primary Outcome Measures:
  • 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:
  • percentage of infants with gastrointestinal adverse events [ Time Frame: 4-week ]
  • percentage of infants with adverse events [ Time Frame: 4-week ]

Enrollment: 534
Actual Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Isomil Advance with LCP
4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01809951


Locations
Indonesia
Divisi Alergi Imunologi FKUI RSCM
Jakarta, Indonesia, 10430
Sponsors and Collaborators
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
  More Information

Responsible Party: Melva Louisa, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT01809951     History of Changes
Other Study ID Numbers: ANID-1101
First Submitted: January 25, 2013
First Posted: March 13, 2013
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:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate