Use of a Peptide-based Formula in an Adult Population

Malabsorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750787
• Other study ID #: DA12
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: July 21, 2017
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malabsorption
• Malabsorption Syndromes

Intervention

Other:
• Nutritional Study Product
Two 220 ml servings per day

Locations

Country	Name	City	State
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Product Consumption	Subject Diary	Day 1 to Day 23
Secondary	Body Mass Index	Calculated from Height and Weight	Change from Screening to Day 23
Secondary	Medication Use	Subject Interview of Dose, Unit and Frequency	Screening to Study Day 23
Secondary	Adverse Events		Screening to Day 25