Back to resultsUse of a Peptide-based Formula in an Adult Population
Primary Purpose
Malabsorption
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nutritional Study Product
Sponsored by
About this trial
This is an interventional other trial for Malabsorption
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years of age.
- Subject has chronic malabsorption or maldigestion.
- Subject requires supplemental nutrition as assessed by a clinician.
- Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period.
Exclusion Criteria:
- Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study.
- Subject has current active malignant disease or was treated within the last 6 months for cancer.
- Subject has a history of diabetes mellitus.
- Subject is pregnant as demonstrated by a urine pregnancy test.
- Subject has severe auto immune disease and is on immuno-modulating therapy.
- Subject has a history of allergy to any of the ingredients in the study product.
- Subject has active HIV.
- Subject has a known aversion to flavor of product being tested.
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption.
- Subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product.
- Subject is taking part in another non-Sponsor approved clinical trial.
Sites / Locations
- St. Boniface Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nutritional Study Product
Arm Description
A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.
Outcomes
Primary Outcome Measures
Study Product Consumption
Subject Diary
Secondary Outcome Measures
Body Mass Index
Calculated from Height and Weight
Medication Use
Subject Interview of Dose, Unit and Frequency
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02750787
Brief Title
Use of a Peptide-based Formula in an Adult Population
Official Title
An Evaluation of the Use of a Peptide-based Formula in an Adult Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malabsorption
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional Study Product
Arm Type
Experimental
Arm Description
A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.
Intervention Type
Other
Intervention Name(s)
Nutritional Study Product
Intervention Description
Two 220 ml servings per day
Primary Outcome Measure Information:
Title
Study Product Consumption
Description
Subject Diary
Time Frame
Day 1 to Day 23
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Calculated from Height and Weight
Time Frame
Change from Screening to Day 23
Title
Medication Use
Description
Subject Interview of Dose, Unit and Frequency
Time Frame
Screening to Study Day 23
Title
Adverse Events
Time Frame
Screening to Day 25
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years of age.
Subject has chronic malabsorption or maldigestion.
Subject requires supplemental nutrition as assessed by a clinician.
Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period.
Exclusion Criteria:
Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study.
Subject has current active malignant disease or was treated within the last 6 months for cancer.
Subject has a history of diabetes mellitus.
Subject is pregnant as demonstrated by a urine pregnancy test.
Subject has severe auto immune disease and is on immuno-modulating therapy.
Subject has a history of allergy to any of the ingredients in the study product.
Subject has active HIV.
Subject has a known aversion to flavor of product being tested.
Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption.
Subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product.
Subject is taking part in another non-Sponsor approved clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Nelson, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Use of a Peptide-based Formula in an Adult Population
We'll reach out to this number within 24 hrs