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OpenTrials
Completed

NCT Number: NCT02750787

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Study Product

Other

Two 220 ml servings per day

Primary outcomes

  1. Study Product Consumption

    Time frame: Day 1 to Day 23

    Subject Diary

Secondary outcomes

  1. Body Mass Index

    Time frame: Change from Screening to Day 23

    Calculated from Height and Weight

  2. Medication Use

    Time frame: Screening to Study Day 23

    Subject Interview of Dose, Unit and Frequency

  3. Adverse Events

    Time frame: Screening to Day 25

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2016
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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