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NCT01809951 Clinical Trial

Isomil Post Marketing Observational Study

Cow's Milk Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01809951
Other study ID # ANID-1101
Secondary ID
Status Completed
Phase N/A
First received January 25, 2013
Last updated June 14, 2017
Start date August 2011
Est. completion date July 2013

Study information
Verified date June 2017
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 534
Est. completion date July 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group 6 Months to 12 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia Divisi Alergi Imunologi FKUI RSCM Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Melva Louisa

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 percentage of infants with gastrointestinal adverse events 4-week
Secondary percentage of infants with adverse events 4-week
See also
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Recruiting NCT02149134 - Evaluation of the Efficacy of a New Infant Formula in Subjects With Cow's Milk Allergy Phase 2
Recruiting NCT01891916 - Effect Of Lactobacillus GG on Atopic March N/A
Completed NCT01634490 - Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy N/A
Completed NCT01622426 - Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy N/A
Completed NCT02466035 - Epigenetic Effects Involved in Children With Cow's Milk Allergy (EPICMA) N/A
Completed NCT02379598 - Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy N/A
Completed NCT04330092 - Diagnosis of Cow's Milk Protein Allergy
Not yet recruiting NCT02081651 - Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy Phase 3
Completed NCT03462030 - Baked Milk Oral Immunotherapy for Cow's Milk Allergy Phase 2
Completed NCT02465905 - Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study N/A
Suspended NCT05731206 - Hypoallergenicity of a Hydrolyzed Protein Infant Formula N/A
Not yet recruiting NCT06456541 - Infant Formula in Infants and Children With Cow's Milk Allergy N/A
Recruiting NCT02062476 - Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy Phase 2
Completed NCT01589731 - Polymerized Beta-lactoglobulin Comparative Immunoreactivity N/A
Terminated NCT02405923 - Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy N/A
Terminated NCT04910373 - Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy N/A
Recruiting NCT01968278 - Use of Baked Milk in Oral Immunotherapy for Severe IgE-mediated Cow's Milk Protein Allergic Patients N/A
Withdrawn NCT01470768 - Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas N/A
Recruiting NCT05883384 - Validity of Cow's Milk-related Symptom Score Among Children Suspected to Have Cow's Milk Protein Alergy