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Isomil Post Marketing Observational Study

NCT01809951 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 534

Last updated 2017-06-16

No results posted yet for this study

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.

Conditions

  • Cow's Milk Allergy

Sponsors & Collaborators

  • Melva Louisa

    lead OTHER

Principal Investigators

  • Zakiudin Munasir, MD, PhD · Division of allergy and Immunology, Department of Child Health, Faculty of Medicine, Universitas Indonesia

  • Sumadiono, MD, PhD · RS Sardjito, Jl Kesehatan No 1 Yogyakarta

  • Anang Endaryanto, MD, PhD · Allergy Immunology Working Unit, East Java Branch of Indonesian Pediatric Society

  • Dina Muktiarti, MD · Sub Divisi Alergi Imunologi IKA FKUI, Jakarta

  • Dewi Kumara Wati, MD, PhD · RSUP Sanglah, Jl Kesehatan No 1-10 Denpasar Bali

  • Budi Setiabudiawan, MD, PhD · RS Hasan Sadikin Jl Pasteur No 38 Bandung

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-04-30
Completion
2013-07-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809951 on ClinicalTrials.gov