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

Abbott

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Diseases; Feeding Intolerance

Treatments: Other: Peptide based enteral formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191112

BK87

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 1 to 13 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Peptide Based enteral formula

Experimental group

Treatment:

Other: Peptide based enteral formula