Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191112

Enrollment

Registered

2010-08-30

Start date

2011-01-31

Completion date

2011-11-30

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Intolerance, Gastrointestinal Diseases

Brief summary

The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.

Interventions

OTHERPeptide based enteral formula

Sole source nutrition as per HCP

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 13 Years

Healthy volunteers

Inclusion criteria

* Male or nonpregnant female between 1 and 13 years of age. * Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance. * Subject requires enteral tube feeding as sole source of nutrition.

Exclusion criteria

* History of diabetes. * Requires artificial ventilation. * Requires parenteral nutrition. * Subject has intestinal obstruction. * Subject is receiving dialysis treatment. * Subject has an allergy or intolerance to any ingredient in the study product.

Design outcomes

Primary

Measure	Time frame
Stool frequency	14 Days
Frequency and intensity of irritability, vomiting, distension	14 Days

Secondary

Measure	Time frame
Average Energy Intake	14 Days
Anthropometrics	14 Days
Medication Use	14 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026