Use of a Peptide-based Formula in an Adult Population
Not Applicable
Completed
- Conditions
- Malabsorption
- Interventions
- Other: Nutritional Study Product
- Registration Number
- NCT02750787
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nutritional Study Product Nutritional Study Product A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.
- Primary Outcome Measures
Name Time Method Study Product Consumption Day 1 to Day 23 Subject Diary
- Secondary Outcome Measures
Name Time Method Medication Use Screening to Study Day 23 Subject Interview of Dose, Unit and Frequency
Adverse Events Screening to Day 25 Body Mass Index Change from Screening to Day 23 Calculated from Height and Weight
Trial Locations
- Locations (1)
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada