NCT01191112

CompletedPhase 3

Evaluation of the Safe Use and Tolerance of a Peptide-based ...

Abbott Nutrition Source

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Other study identifiers

Sponsor study identifier

BK87

Study Type

interventional

Actual enrollment (reported)

27

Locations

1 country

Sites

1

Timeline

Study Start

January 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2011

Actual (reported)

Study Completion

November 2011

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 27 participants
Study completion date: November 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 27, 2010
Actual (reported)
First Posted
August 30, 2010
Actual (reported)
Study Start
January 2011
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2011
Actual (reported)
Study Completion
November 2011
Actual (reported)

Last Updated: March 3, 2015
Status Verified: March 2015
Last Update Submitted: March 2, 2015

Conditions

Feeding Intolerance Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (3)

Average Energy Intake
14 Days
Anthropometrics
14 Days
Medication Use
14 days

Study Arms (1)

Peptide Based enteral formula

EXPERIMENTAL

Other: Peptide based enteral formula

Interventions

Peptide based enteral formulaOther

Sole source nutrition as per HCP

Peptide Based enteral formula

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Year - 13 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Male or nonpregnant female between 1 and 13 years of age.
Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.

Sponsors & Collaborators

Abbott Nutrition
Industrylead

Study Sites (1)

University of Alberta, Stollery Children's Hospital

Edmonton, Alberta, T6G2J3, Canada

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

Jennifer Williams, MPH
Abbott Nutrition
STUDY CHAIR

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

January 2011

Date type not reported

This date has not been verified as actual or estimated.

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Not ApplicableCompleted

NCT00997854

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Nexium Dyspepsia/AST

Nexium Dyspepsia/AST

A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2

Phase 3Completed

Subject requires enteral tube feeding as sole source of nutrition.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

November 2011

Actual (reported)

Study Completion

November 2011

Actual (reported)

Last Updated

March 3, 2015

Record last verified: 2015-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01191112
Data provider: ClinicalTrials.gov
Source updated: 2015-03-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:14 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Peptide Based enteral formula

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations