Evaluation of the Safe Use and Tolerance of a Peptide-bas... | NCT01191112

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

NCT01191112

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

27Actual

Phase

Phase 3

Conditions

Gastrointestinal Diseases
Feeding Intolerance

Interventions

Peptide based enteral formula

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Aug 27, 2010

First Submission Date that Met QC Criteria

Aug 27, 2010

First Posted Date

Aug 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peptide Based enteral formula	Experimental		Other: Peptide based enteral formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peptide based enteral formula	Other	Sole source nutrition as per HCP	Peptide Based enteral formula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Average Energy Intake		14 Days
Anthropometrics		14 Days
Medication Use

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Williams, MPH	Abbott Nutrition	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta, Stollery Children's Hospital		Edmonton	Alberta	T6G2J3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided