Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis (MBT)

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis; Exocrine Pancreatic Insufficiency; Recurrent Acute Pancreatitis
• Intervention / Treatment: Diagnostic test: MBT1; Diagnostic test: MBT 2; Drug: Pancreatic Enzyme Replacement Therapy; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anna E Phillips, MD MS; Phone Number: 412-864-7096; Email: evansac3@upmc.edu
• Study Contact Backup: Name: Apsara Mishra, BSC; Phone Number: 412-383-2447; Email: apm179@pitt.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins Medicine
      • Contact: Yeganeh Pasebani, MD; Phone Number: 410-955-5000; Email: ypaseba1@jh.edu
      • Principal Investigator: Vikesh K Singh, MD MSc
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Anna E Phillips, MD MS; Phone Number: 412-864-7096; Email: evansac3@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: MBT1; MBT off PERT; Diagnostic test: MBT 2; MBT on PERT
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.	Diagnostic test: MBT1; MBT off PERT; Diagnostic test: MBT 2; MBT on PERT
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.	Diagnostic test: MBT1; MBT off PERT; Diagnostic test: MBT 2; MBT on PERT; 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)
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.	Diagnostic test: MBT1; MBT off PERT; Diagnostic test: MBT 2; MBT on PERT; Drug: Placebo; 12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
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.	Diagnostic test: MBT1; MBT off PERT; Diagnostic test: MBT 2; MBT on PERT; 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)
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.	Diagnostic test: MBT1; MBT off PERT; Diagnostic test: MBT 2; MBT on PERT; Drug: Placebo; 12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome (Aim 1)	The primary outcome of the first phase of the study will be the prevalence of responders to PERT by assessing Heptadecanoic Acid absorption following 5-days of PERT therapy compared to baseline (no PERT therapy). This will be measured by a positive area under the curve of the difference between absorption curves for Triheptadecanoic Acid and Pentadecanoic Acid.	2 weeks
Primary Outcome (Aim 2)	The primary outcome of the second phase of the study will be change in the Overall Quality of Life Score of the Patient Reported Outcomes Measurement Systems (PROMIS) 29 + 2 questionnaire for subjects receiving PERT compared to placebo.	Baseline (at time of entry to RCT) to completion of RCT, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome: PROMIS Gastrointestinal Symptom Score for Belly Pain	The PROMIS gastrointestinal symptoms short form for belly pain will be used to track symptoms of EPI over the course of the 8 week trial and change in this will be assessed comparing the cohorts receiving PERT and placebo. Range 0-25. Higher score equals worse belly pain.	8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Bowel Incontinence	The PROMIS gastrointestinal symptoms short form for bowel incontinence will be used to track symptoms of EPI over the course of the 8 week trial. This will be assessed as a secondary outcomes, comparing change between the cohorts receiving PERT and placebo. Range 4-20. Higher score equals more bowel incontinence.	8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Constipation	The PROMIS gastrointestinal symptoms short form for constipation will be used to track symptoms of EPI over the course of the 8 week trial. This will be assessed as a secondary outcome, comparing change between the cohorts receiving PERT and placebo. Ragne 8-45. Higher score equals worse constipation.	8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Diarrhea	The PROMIS gastrointestinal symptoms short form for diarrhea will be used to track symptoms of EPI over the course of the 8 week trial. This will be assessed as a secondary outcome, comparing change between the cohorts receiving PERT and placebo. Range 5-30. Higher score equals worse diarrhea.	8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Nausea and Vomiting	The PROMIS gastrointestinal symptoms short form for nausea and vomiting will be used to track symptoms of EPI over the course of the 8 week trial. This will be assessed as a secondary outcome, comparing change between the cohorts receiving PERT and placebo. Range 3-20. Higher score equals worse nausea and vomiting.	8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Gas and Bloating	The PROMIS gastrointestinal symptoms short form for gas and bloating will be used to track symptoms of EPI over the course of the 8 week trial. This will be assessed as a secondary outcome, comparing change between the cohorts receiving PERT and placebo. Ragne 4-65. Higher score equals worse gas and bloating.	8 weeks

Collaborators and Investigators

• Sponsor: Anna Evans Phillips
• Collaborators: Johns Hopkins University; Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Digestive Care, Inc.
• Investigators: Principal Investigator: Anna E Phillips, MD MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic pancreatitis; Exocrine Pancreatic Insufficiency; Malabsorption Blood Test(MBT); Recurrent Acute pancreatitis
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: STUDY25030126; R01DK140381 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is not planning to be shared except in conjunction with any NIH or NIDDK policies that include this requirement, in which case all active policies will be followed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No