Use of a Peptide-based Formula in an Adult Population

An Evaluation of the Use of a Peptide-based Formula in an Adult Population

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.

Study Overview

• Status: Completed
• Conditions: Malabsorption
• Intervention / Treatment: Other: Nutritional Study Product

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Study Product; A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.	Other: Nutritional Study Product; Two 220 ml servings per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Product Consumption	Subject Diary	Day 1 to Day 23

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Calculated from Height and Weight	Change from Screening to Day 23
Medication Use	Subject Interview of Dose, Unit and Frequency	Screening to Study Day 23
Adverse Events		Screening to Day 25

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jeffrey L Nelson, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes
• Other Study ID Numbers: DA12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED