Use of a Peptide-based Formula in an Adult Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malabsorption

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nutritional Study Product

A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.

Group Type EXPERIMENTAL

Nutritional Study Product

Intervention Type OTHER

Two 220 ml servings per day

Interventions

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Nutritional Study Product

Two 220 ml servings per day

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No