Clinical Trials Logo
  1. Home
  2. Gastrointestinal Diseases
  3. NCT01191112
  4. Details
NCT01191112 Clinical Trial

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

Gastrointestinal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01191112
Other study ID # BK87
Secondary ID
Status Completed
Phase Phase 3
First received August 27, 2010
Last updated March 2, 2015
Start date January 2011
Est. completion date November 2011

Study information
Verified date March 2015
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 13 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Peptide based enteral formula
Sole source nutrition as per HCP

Locations
Country Name City State
Canada University of Alberta, Stollery Children's Hospital Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stool frequency 14 Days No
Primary Frequency and intensity of irritability, vomiting, distension 14 Days No
Secondary Average Energy Intake 14 Days No
Secondary Anthropometrics 14 Days No
Secondary Medication Use 14 days No
See also
  Status Clinical Trial Phase
Terminated NCT02541357 - Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery N/A
Active, not recruiting NCT02358122 - Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh N/A
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Enrolling by invitation NCT00943345 - Validation of New Tests for Gastrointestinal (GI) Permeability Phase 0
Completed NCT00612404 - Symptoms and Endoscopic Results in Consideration of Pretreatment N/A
Completed NCT01127711 - Cohort of Swedish Men N/A
Recruiting NCT05712525 - Gut Recovery In Patients Following Surgery
Recruiting NCT06094153 - Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function N/A
Recruiting NCT05322486 - Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases
Completed NCT02486146 - GI Biorepository of Tissue and Bodily Fluids N/A
Completed NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT00247715 - Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study) N/A
Completed NCT00035334 - Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Phase 2/Phase 3
Recruiting NCT06286865 - Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial N/A
Active, not recruiting NCT01037049 - Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks Phase 2
Completed NCT03725813 - Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit N/A
Recruiting NCT05640401 - Holographic Screens as a Replacement of Monitors During GI Endoscopies N/A
Completed NCT02865564 - Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics N/A
Completed NCT02651857 - Exploratory Study of Upper and Lower Endoscopic Fuse System N/A
Active, not recruiting NCT01984034 - Trial to Assess the Effectiveness of Educational Outreach in Prescription Guidelines N/A