Use of a Peptide-based Formula in an Adult Population

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Abbott

Status

Completed

Conditions

Malabsorption

Treatments

Other: Nutritional Study Product

Study type

Interventional

Funder types

Industry

Identifiers

NCT02750787
DA12

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

Nutritional Study Product
Experimental group
Description:
A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.
Treatment:
Other: Nutritional Study Product

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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