Complex Conditions, Including Impairment of the GI Tract Clinical Trial
Official title:
An Open-label, Explorative, Post Launch Study of Neocate Amino Acid-based Feeds to Evaluate Nutritional Status and Gastrointestinal Tolerance in Infants and Children With Complex Conditions
Infants and young children up to 10 years of age with a complex condition involving the
gastrointestinal tract are at risk of poor nutritional status, including faltering growth.
Due to the complex condition, standard nutrition is often not tolerated and causes
gastrointestinal symptoms.
Formulas in which protein is replaced by its smallest elements, amino acids are easier for
the body to digest and absorb. These formulas might be tolerated better and reduce
gastrointestinal symptoms in infants and young children with complex conditions.
The objectives of the present, exploratory study are to gain clinical evidence related to the
nutritional status and gastrointestinal tolerance in infants and young children with complex
conditions receiving Neocate as their primary source of nutrition. Additional objectives are
to describe the nutritional and pharmacological management of these infants and young
children. Study duration for each participant will be 52 weeks at maximum.
n/a