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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02849704 |
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Date of registration:
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27/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fat Malabsorption in Chronic Pancreatitis
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Scientific title:
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Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis |
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Date of first enrolment:
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October 13, 2016 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02849704 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Virginia Stallings, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Name:
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Babette Zemel, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria (CP):
- Chronic pancreatitis diagnosis by gastroenterologist. Participants with CP will be
characterized based on the TIGAR-O (toxic, genetic, autoimmune, recurrent,
obstructive) etiology system, on pancreatic morphology (Cambridge criteria) when
available, and on physiological state (exocrine and endocrine function) as recommended
by the recent American Pancreatic Association Practice Guidelines4.
- Age 30-70 years old
- Evidence of at-risk for malabsorption including: 1) history of use of and response to
pancreatic enzyme medication; 2) history of unintentional weight loss; 3) history of
increased stools per week or fatty stools; and/or 4) other clinical signs or symptoms
suggestive of fat malabsorption
- In usual state of health for past two weeks including no change in medications
- Able to consume a moderate fat diet for stool evaluations
- Able to participate in the study for about four weeks with two study visits
Inclusion Criteria (Healthy Volunteers):
- Age 30-70 years old
- No known chronic disease that would affect dietary intake or fat absorption
- In usual state of health for past two weeks, with stable medications, diet and weight
- BMI from 18-29
- Able to consume a moderate fat diet for stool evaluations
- Able to participate in the study for about one week with one study visit
Exclusion Criteria (CP):
- Evidence of normal fat absorption in medical record
- Medications that alter fat absorption (i.e. orlistat, other weight loss medications,
ursodeoxycholic acid)
- Allergy to pork products
- History of intestinal blockage or fibrosing colonopathy
- History of gout, kidney disease, or high blood uric acid (hyperuricemia)
- Pregnancy or breast feeding
Exclusion Criteria (Healthy Volunteers):
- Evidence of fat malabsorption
- Medications that alter fat absorption (i.e. orlistat, other weight loss medications,
ursodeoxycholic acid)
- Pregnancy or breast feeding
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Pancreatitis
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Intervention(s)
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Drug: Creon36™
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Primary Outcome(s)
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Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects
[Time Frame: 72 hours]
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Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects
[Time Frame: 8 hours]
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Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects
[Time Frame: 72 hours]
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Secondary Outcome(s)
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Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™
[Time Frame: 72 hours]
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Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™
[Time Frame: 72 hours]
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Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™
[Time Frame: 8 hours]
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Secondary ID(s)
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16-013001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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