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

April 21, 2026 updated by: Anna Evans Phillips
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Principal Investigator:
          • Vikesh K Singh, MD MSc
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome (Aim 1)
Time Frame: 2 weeks
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)
Time Frame: Baseline (at time of entry to RCT) to completion of RCT, 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome: PROMIS Gastrointestinal Symptom Score for Belly Pain
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anna Evans Phillips

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Children's Hospital of Philadelphia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Digestive Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna E Phillips, MD MS, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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