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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Anna Evans Phillips
Study ID
NCT07418593
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)
  • Placebo — DRUG
    12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
  • MBT1 — DIAGNOSTIC_TEST
    MBT off PERT
  • MBT 2 — DIAGNOSTIC_TEST
    MBT on PERT

Study Details

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).

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Primary Outcome (Aim 1) [ Time Frame: 2 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins MedicineBaltimoreMaryland21287
Yeganeh Pasebani, MD
[email protected]
410-955-5000
Vikesh K Singh, MD MSc (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Anna E Phillips, MD MS
[email protected]
412-864-7096

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By research site
Johns Hopkins Medicine· Baltimore, MDUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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