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Use of a Peptide-based Formula in an Adult Population

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ClinicalTrials.gov Identifier: NCT02750787
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief 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.

Condition or disease Intervention/treatment Phase
Malabsorption Other: Nutritional Study Product Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Evaluation of the Use of a Peptide-based Formula in an Adult Population
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Study Product Consumption [ Time Frame: Day 1 to Day 23 ]
    Subject Diary


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750787


Locations
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Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Jeffrey L Nelson, PhD Abbott Nutrition

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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02750787     History of Changes
Other Study ID Numbers: DA12
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases