Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Purpose
This project uses the Malabsorption Blood Test (MBT) to identify patients with recurrent acute or chronic pancreatitis who have mild to moderate exocrine pancreatic insufficiency. A subgroup of patients who have response to pancreatic enzyme replacement therapy will enter a randomized, placebo-controlled pilot clinical trial for 8 weeks to identify improvements in quality of life (QOL).
Conditions
- Chronic Pancreatitis
- Recurrent Acute Pancreatitis
- Exocrine Pancreatic Insufficiency
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 18 years of age - RAP (≥ 2 documented lifetime attacks with ≥ 2 of 3 acute pancreatitis criteria) OR Chronic pancreatitis (Cambridge I or II with documented history of AP OR Cambridge III or IV criteria) - Fecal elastase ≥ 50 within the preceding 12 months
Exclusion Criteria
- Allergy/Intolerance to PERT/MBT - Taking medications that alter fat absorption or that supplement the fatty acids being studied (e.g. orlistat, ursodeoxycholic acid, Fatty-15 fatty acid supplement etc.) - Taking GLP-1 Receptor Agonist therapy - Fecal elastase <50 within preceding 12 months OR pre-existing diagnosis of severe Exocrine Pancreatic Insufficiency, or ongoing steatorrhea - Receiving Pancreatic Enzyme Replacement Therapy for > 5 days within the preceding 30 days - Acute Pancreatitis attack (documented and meeting at least 2 of 3 criteria) within the preceding 90 days - History of pancreatic resection or underlying malabsorptive disease - Pregnant or Breast Feeding - Other significant medical condition as judged by Principal Investigator
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- All enrolled subjects will undergo 2 Malabsorption Blood Tests(MBT), one off PERT [MBT1], and one on PERT [MBT2]) to determine their fat malabsorption response to PERT. Those who have an increase in Heptadecanoic Acid absorption on PERT will be determined to be responders to PERT. Of those subjects that are deemed to be responders, the first 24 will be randomized to the second phase of the study, which is a randomized placebo-controlled clinical trial (RCT). Subjects in the RCT will be given 8 weeks of PERT or 8 weeks of placebo and Quality of Life Measures will be determined at the outset and completion of the trial to assess changes that associate with PERT use compared to placebo.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Active Comparator MBT1-MBT2 |
Participants will undergo the MBT off PERT followed by the MBT on PERT. They will not be enrolled in the randomized trial. |
|
|
Active Comparator MBT2-MBT1 |
Participants will undergo MBT on PERT followed by MBT off PERT. Participants will not be enrolled in the randomized clinical trial. |
|
|
Active Comparator MBT1-MBT2 Pancreatic Enzyme |
Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with PERT. |
|
|
Active Comparator MBT1-MBT2 Placebo |
Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with placebo. |
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|
Active Comparator MBT2-MBT1 PERT |
Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with PERT. |
|
|
Active Comparator MBT2-MBT1 Placebo |
Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with placebo. |
|
Recruiting Locations
Pittsburgh, Pennsylvania 15213
More Details
- Status
- Recruiting
- Sponsor
- Anna Evans Phillips
Detailed Description
This proposal uses a blood test detection method for EPI specifically designed to detect fat malabsorption in the setting of inadequate release of pancreatic digestive enzymes. The purpose of using it in this study is to identify mild and moderate EPI, for which to date no reliable test exists. The MBT evaluates the absorption of heptadecanoic acid (HA), a fatty acid dependent on lipase to release it from more complex form before it can be absorbed. Steatorrhea (fatty diarrhea) is a symptom present in over half of subjects with severe EPI, but is frequently not present in mild or moderate forms of EPI. In the absence of overt steatorrhea, there exists no reliable test to detect mild or moderate EPI in subjects with RAP or CP or track response to treatment. Without detection, RAP and CP subjects are at risk for malnutrition if they cannot properly absorb dietary fat and nutrients, and simultaneously significant weight loss, sarcopenia, osteopathy, nutritional deficiencies, GI symptoms and QOL. There is a clear medical need to identify subjects with pancreatic fat malabsorption who will benefit from treatment for EPI - pancreatic enzyme replacement therapy (PERT). In the proposed work, the investigators will enroll 80 subjects with RAP or CP who do not have steatorrhea or known severe EPI, and perform the MBT before and after 5 days of PERT therapy to identify subjects with fat malabsorption responsive to PERT. The investigators will assess clinical factors that correlate with PERT-responsive fat malabsorption. The primary outcome for assessment of the MBT results will be prevalence of PERT-responsive fat malabsorption. It is anticipated that 33% of subjects will have PERT-responsive fat malabsorption. The investigators will then sequentially enroll 24 PERT-responders to an 8-week pilot randomized placebo-controlled clinical trial of PERT supplementation (144,000 lipase units per day) versus placebo to determine the effects on QOL. The hypothesis is that PERT will result in improvement of QOL defined by a positive change from baseline in the PROMIS 29+2 in PERT-responders. PROMIS Gastrointestinal Scales will be assessed as secondary outcomes. Change in the results of a short physical performance battery and changes in body morphology (weight, BMI) from beginning of the study will be assessed in an exploratory fashion for correlation with PERT administration versus placebo.