Malabsorption
Conditions
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.
Interventions
OTHERNutritional Study Product
Two 220 ml servings per day
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Product Consumption | Day 1 to Day 23 | Subject Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Change from Screening to Day 23 | Calculated from Height and Weight |
| Medication Use | Screening to Study Day 23 | Subject Interview of Dose, Unit and Frequency |
| Adverse Events | Screening to Day 25 | — |
Countries
Canada
Outcome results
None listed