Recruiting

Malabsorption Blood Test

Sponsor:

Anna Evans Phillips

Code:

NCT07418593

Conditions

Chronic Pancreatitis

Recurrent Acute Pancreatitis

Exocrine Pancreatic Insufficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pancreatic Enzyme Replacement Therapy

Placebo

MBT1

MBT 2

Study Details

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

Study ID

NCT07418593

Start date

Apr 20, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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)

Placebo

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

MBT1

MBT off PERT

MBT 2

MBT on PERT

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Anna E Phillips, MD MS

412-864-7096Evansac3@upmc.edu

Apsara Mishra, BSC

412-383-2447apm179@pitt.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Anna E Phillips, MD MS

412-864-7096evansac3@upmc.edu

More Information

Sponsor

Anna Evans Phillips

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anna Evans Phillips on 2026-04-27.