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

NCT07418593 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-27

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

Principal Investigators

  • Anna E Phillips, MD MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2028-06-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418593 on ClinicalTrials.gov