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OpenTrials
Completed

NCT Number: NCT01809951

Isomil Post Marketing Observational Study

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.

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Key information

Conditions

Cow's Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Divisi Alergi Imunologi FKUI RSCM

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. percentage of infants with gastrointestinal adverse events

    Time frame: 4-week

  2. percentage of infants with adverse events

    Time frame: 4-week

Sponsors and collaborators

Lead sponsor

Melva Louisa

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2013
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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