Isomil Post Marketing Observational Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Indonesia University
Sponsor:
Information provided by (Responsible Party):
Melva Louisa, Indonesia University
ClinicalTrials.gov Identifier:
NCT01809951
First received: January 25, 2013
Last updated: March 11, 2013
Last verified: March 2013
  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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • percentage of infants with gastrointestinal adverse events [ Time Frame: 4-week ] [ Designated as safety issue: Yes ]
  • percentage of infants with adverse events [ Time Frame: 4-week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2250
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated 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

Ages Eligible for Study:   6 Months to 12 Months
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809951

Contacts
Contact: Dina Muktiarti, MD +62213161144 dinamuktiarti@yahoo.com

Locations
Indonesia
Divisi Alergi Imunologi FKUI RSCM Recruiting
Jakarta, Indonesia, 10430
Contact: Dina Muktiarti, MD    +62213161144    dinamuktiarti@yahoo.com   
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

No publications provided

Responsible Party: Melva Louisa, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT01809951     History of Changes
Other Study ID Numbers: ANID-1101
Study First Received: January 25, 2013
Last Updated: March 11, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014