Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pancreatic Enzyme Replacement Therapy, Placebo, MBT1, MBT 2.
- Who it may be relevant to
- Registry conditions: Chronic Pancreatitis, Recurrent Acute Pancreatitis, Exocrine Pancreatic Insufficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
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.
Interventions
- Drug Pancreatic Enzyme Replacement Therapy
12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily) - Drug Placebo
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy - Diagnostic test MBT1
MBT off PERT - Diagnostic test MBT 2
MBT on PERT
Primary outcome measures
- Primary Outcome (Aim 1) [Time frame: 2 weeks]
- Primary Outcome (Aim 2) [Time frame: Baseline (at time of entry to RCT) to completion of RCT, 8 weeks]
Secondary outcome measures (6)
- Secondary Outcome: PROMIS Gastrointestinal Symptom Score for Belly Pain [Time frame: 8 weeks]
- Secondary Outcome: PROMIS Gastrointestinal Scale for Bowel Incontinence [Time frame: 8 weeks]
- Secondary Outcome: PROMIS Gastrointestinal Scale for Constipation [Time frame: 8 weeks]
- Secondary Outcome: PROMIS Gastrointestinal Scale for Diarrhea [Time frame: 8 weeks]
- Secondary Outcome: PROMIS Gastrointestinal Scale for Nausea and Vomiting [Time frame: 8 weeks]
- Secondary Outcome: PROMIS Gastrointestinal Scale for Gas and Bloating [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Johns Hopkins Medicine — Baltimore
- University of Pittsburgh Medical Center — Pittsburgh
Identifiers
NCT: NCT07418593 · STUDY25030126 · R01DK140381