Use of a Peptide-based Formula in an Adult Population
An Evaluation of the Use of a Peptide-based Formula in an Adult Population
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 24, 2017
July 1, 2017
11 months
April 19, 2016
July 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Study Product Consumption
Subject Diary
Day 1 to Day 23
Secondary Outcomes (3)
Body Mass Index
Change from Screening to Day 23
Medication Use
Screening to Study Day 23
Adverse Events
Screening to Day 25
Study Arms (1)
Nutritional Study Product
EXPERIMENTALA ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeffrey L Nelson, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 26, 2016
Study Start
August 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
July 24, 2017
Record last verified: 2017-07