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COMPLETED
NCT04265729
NA

Neocate In Infants and Children With Complex Conditions

Sponsor: Nutricia Research

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

0 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2021-07-01

Completion Date

2023-07-24

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Neocate Infant and Junior marketed products

use of Neocate Infant and Junior marketed products

Locations (4)

GI Care for Kids

Atlanta, Georgia, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Dr. von Haunersches LKinderspital

Munich, Germany

Great Ormond Street Hospital

London, United Kingdom