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

NCT07418593 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: STUDY25030126R01DK140381
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Malabsorption Blood Test(MBT); Chronic pancreatitis; Recurrent Acute pancreatitis; Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Secondary Outcome: PROMIS Gastrointestinal Symptom Score for Belly Pain

  8 weeks

• Secondary Outcome: PROMIS Gastrointestinal Scale for Bowel Incontinence

  8 weeks

• Secondary Outcome: PROMIS Gastrointestinal Scale for Constipation

  8 weeks

• Secondary Outcome: PROMIS Gastrointestinal Scale for Diarrhea

  8 weeks

• Secondary Outcome: PROMIS Gastrointestinal Scale for Nausea and Vomiting

  8 weeks

Study Arms (6)

MBT1-MBT2

ACTIVE COMPARATOR

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; Diagnostic Test: MBT 2

MBT2-MBT1

ACTIVE COMPARATOR

Participants will undergo MBT on PERT followed by MBT off PERT. Participants will not be enrolled in the randomized clinical trial.

Diagnostic Test: MBT1; Diagnostic Test: MBT 2

MBT1-MBT2 Pancreatic Enzyme

ACTIVE COMPARATOR

Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with PERT.

Drug: Pancreatic Enzyme Replacement Therapy; Diagnostic Test: MBT1; Diagnostic Test: MBT 2

MBT1-MBT2 Placebo

ACTIVE COMPARATOR

Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with placebo.

Drug: Placebo; Diagnostic Test: MBT1; Diagnostic Test: MBT 2

MBT2-MBT1 PERT

ACTIVE COMPARATOR

Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with PERT.

Drug: Pancreatic Enzyme Replacement Therapy; Diagnostic Test: MBT1; Diagnostic Test: MBT 2

MBT2-MBT1 Placebo

ACTIVE COMPARATOR

Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with placebo.

Drug: Placebo; Diagnostic Test: MBT1; Diagnostic Test: MBT 2

Interventions

Pancreatic Enzyme Replacement Therapy DRUG

12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)

MBT1-MBT2 Pancreatic Enzyme; MBT2-MBT1 PERT

Placebo DRUG

12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy

MBT1-MBT2 Placebo; MBT2-MBT1 Placebo

MBT1 DIAGNOSTIC_TEST

MBT off PERT

MBT1-MBT2; MBT1-MBT2 Pancreatic Enzyme; MBT1-MBT2 Placebo; MBT2-MBT1; MBT2-MBT1 PERT; MBT2-MBT1 Placebo

MBT 2 DIAGNOSTIC_TEST

MBT on PERT

MBT1-MBT2; MBT1-MBT2 Pancreatic Enzyme; MBT1-MBT2 Placebo; MBT2-MBT1; MBT2-MBT1 PERT; MBT2-MBT1 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Evans Phillips: lead
• Johns Hopkins University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Children's Hospital of Philadelphia: collaborator
• Digestive Care, Inc.: collaborator

Study Sites (2)

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna E Phillips, MD MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna E Phillips, MD MS

CONTACT

412-864-7096; Evansac3@upmc.edu

Apsara Mishra, BSC

CONTACT

412-383-2447; apm179@pitt.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)