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Fat Malabsorption in Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT02849704
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
AbbVie
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phoenix Indian Medical Center
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The objective of this study is to evaluate the malabsorption blood test (MBT), stool coefficient of fat absorption (CFA) and stool bomb calorimetry (BC) methods as potential screening or diagnostic tests for reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI). A further objective is to determine the test responses before and after pancreatic enzyme medication administration (Creon36™) in the patients with chronic pancreatitis (CP).

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: Creon36™ Phase 2

Detailed Description:

Reduced exocrine pancreatic function or pancreatic insufficiency (RPF/PI) contributes to poor clinical outcome in a number of diseases and conditions. The incidence, mechanism and substantial adverse clinical outcomes of pancreatic insufficiency (PI) are well known in patients with cystic fibrosis (CF), and the life sustaining role of pancreatic enzyme medication in CF care is well established. Much less is known about the incidence and impact of RPF/PI in patients with chronic pancreatitis (CP). Reliable non-invasive screening or diagnostic tests with acceptable patient burden are not available for RPF/PI.

This is a cohort study of subjects with CP who will be evaluated before and after pancreatic enzyme medication (Creon36™) administration. A cohort of healthy subjects will serve as a comparison group and will be evaluated only once.

Subjects with CP will receive Creon36™, a pancreatic enzyme medication, and fat and energy absorption will be evaluated using three methods: MBT, CFA, and BC before and after administration of Creon36™. Many patients with CP are at risk for RPF/PI yet they rarely undergo diagnostic testing. Pancreatic enzyme medication will likely improve clinical outcomes and quality of life in some of those with RPF/PI. A cohort of healthy volunteers will be evaluated with the three methods to provide essential comparison data to optimize the understanding and interpretation of the findings from the three methods and the RPF/PI cohort with CP. There will be no intervention for the healthy cohort.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosing Pancreatic-Based Malabsorption in Patients With Chronic Pancreatitis
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chronic Pancreatitis (CP) Subjects

CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary.

Subjects will take Creon36™ for 9 days.

Subjects will have two study visits, one before and one after treatment initiation with Creon36™. Both visits will be identical with the exception of completion of questionnaires and fecal elastase assessment (only Visit 1).

Drug: Creon36™
Creon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.
Other Names:
  • Pancrelipase
  • CREON

No Intervention: Healthy Controls
Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.



Primary Outcome Measures :
  1. Difference in mean malabsorption blood test (MBT) between groups [ Time Frame: Up to 72 hours ]
    The fat and energy absorption pattern in CP subjects after treatment with Creon36™ will be compared with healthy controls. Mean MBT will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat and energy absorption pattern between the two groups.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02849704


Contacts
Contact: Carolyn McAnlis, BS 267-426-9381 mcanlisc@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Carolyn McAnlis, BS    267-426-9381    mcanlisc@email.chop.edu   
Sub-Investigator: Virginia Stallings, MD         
Principal Investigator: Babette Zemel, PhD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
AbbVie
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phoenix Indian Medical Center
Investigators
Principal Investigator: Babette Zemel, PhD Children's Hospital of Philadelphia
Study Director: Virginia Stallings, MD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02849704     History of Changes
Other Study ID Numbers: 16-013001
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital of Philadelphia:
Chronic Pancreatitis
Pancreatic Function
Reduced Exocrine Pancreatic Function
Pancreatic Insufficiency

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatitis
Malabsorption Syndromes
Pancreatic Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Metabolic Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents