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

ConditionsChronic PancreatitisRecurrent Acute PancreatitisExocrine Pancreatic Insufficiency
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnna Evans Phillips

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: MBT1-MBT2Active comparator 2 interventions
Group B: MBT2-MBT1Active comparator 2 interventions
Group C: MBT1-MBT2 Pancreatic EnzymeActive comparator 3 interventions
Group D: MBT1-MBT2 PlaceboActive comparator 3 interventions
Group E: MBT2-MBT1 PERTActive comparator 3 interventions
Group F: MBT2-MBT1 PlaceboActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 weeks
2

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.

Time frame
Baseline (at time of entry to RCT) to completion of RCT, 8 weeks

Secondary outcomes

1

Secondary Outcome: PROMIS Gastrointestinal Symptom Score for Belly Pain

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.

Time frame
8 weeks
2

Secondary Outcome: PROMIS Gastrointestinal Scale for Bowel Incontinence

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.

Time frame
8 weeks
3

Secondary Outcome: PROMIS Gastrointestinal Scale for Constipation

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.

Time frame
8 weeks
4

Secondary Outcome: PROMIS Gastrointestinal Scale for Diarrhea

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Evans Phillips

Lead sponsor

University of Pittsburgh

Sponsor institution

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

Source ClinicalTrials.gov
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