Chronic PancreatitisPhase 4MBTNCT07418593
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
A Phase 4 study testing Pancreatic Enzyme Replacement Therapy, MBT1 and MBT 2 in people with Chronic Pancreatitis and Recurrent Acute Pancreatitis, run by Anna Evans Phillips at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Recurrent Acute Pancreatitis, Exocrine Pancreatic Insufficiency
- What is being tested?
- Pancreatic Enzyme Replacement Therapy, MBT1 and MBT 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2026to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 9Show fewer
- History of pancreatic resection or underlying malabsorptive disease
- Pregnant or Breast Feeding
- Other significant medical condition as judged by Principal Investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Yeganeh Pasebani, MD, 410-955-5000, ypaseba1@jh.edu
Vikesh K Singh, MD MSc
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Anna E Phillips, MD MS, 412-864-7096, evansac3@upmc.edu
About this study
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).
Read the 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.
- Being tested
- Pancreatic Enzyme Replacement Therapy, Placebo, MBT1, MBT 2
- Keywords
- Malabsorption Blood Test(MBT), Chronic pancreatitis, Recurrent Acute pancreatitis, Exocrine Pancreatic Insufficiency
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic Enzyme Replacement TherapyDrug
12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)
PlaceboDrug
12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy
MBT1Diagnostic test
MBT off PERT
MBT 2Diagnostic test
MBT on PERT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo; Diagnostic Test: MBT1; Diagnostic Test: MBT 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Nausea and Vomiting
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.
Measured: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Gas and Bloating
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start20 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Evans Phillips
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital of Philadelphia, Digestive Care, Inc.
- Responsible party
- Sponsor-investigator, Anna Evans Phillips, University of Pittsburgh
- Investigators
- Anna E Phillips, MD MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418593
- Sponsor's protocol ID
- STUDY25030126
- Other IDs
- R01DK140381
- Acronym
- MBT
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT07418593
- Acronym / sponsor ID
- MBT / STUDY25030126
- Keywords
- Malabsorption Blood Test(MBT), Chronic pancreatitis, Recurrent Acute pancreatitis, Exocrine Pancreatic Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Anna Evans PhillipsUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital of Philadelphia, Digestive Care, Inc.
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MBT1-MBT2 | Active comparator | Diagnostic Test: MBT1, Diagnostic Test: MBT 2Participants will undergo the MBT off PERT followed by the MBT on PERT. They will not be enrolled in the randomized trial. |
| MBT2-MBT1 | Active comparator | Diagnostic Test: MBT1, Diagnostic Test: MBT 2Participants will undergo MBT on PERT followed by MBT off PERT. Participants will not be enrolled in the randomized clinical trial. |
| MBT1-MBT2 Pancreatic Enzyme | Active comparator | Drug: Pancreatic Enzyme Replacement Therapy, Diagnostic Test: MBT1, Diagnostic Test: MBT 2Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with PERT. |
| MBT1-MBT2 Placebo | Active comparator | Drug: Placebo, Diagnostic Test: MBT1, Diagnostic Test: MBT 2Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with placebo. |
| MBT2-MBT1 PERT | Active comparator | Drug: Pancreatic Enzyme Replacement Therapy, Diagnostic Test: MBT1, Diagnostic Test: MBT 2Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with PERT. |
| MBT2-MBT1 Placebo | Active comparator | Drug: Placebo, Diagnostic Test: MBT1, Diagnostic Test: MBT 2Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic Enzyme Replacement Therapy12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily) | Drug | MBT1-MBT2 Pancreatic Enzyme, MBT2-MBT1 PERT |
| Placebo12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy | Drug | MBT1-MBT2 Placebo, MBT2-MBT1 Placebo |
| MBT1MBT off PERT | Diagnostic test | MBT1-MBT2, MBT1-MBT2 Pancreatic Enzyme, MBT1-MBT2 Placebo, MBT2-MBT1, MBT2-MBT1 PERT, MBT2-MBT1 Placebo |
| MBT 2MBT on PERT | Diagnostic test | MBT1-MBT2, MBT1-MBT2 Pancreatic Enzyme, MBT1-MBT2 Placebo, MBT2-MBT1, MBT2-MBT1 PERT, MBT2-MBT1 Placebo |
Primary outcome
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.
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.
6 secondary outcomes
Secondary Outcome: PROMIS Gastrointestinal Symptom Score for Belly Pain
Time frame: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Bowel Incontinence
Time frame: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Constipation
Time frame: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Diarrhea
Time frame: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Nausea and Vomiting
Time frame: 8 weeks
Secondary Outcome: PROMIS Gastrointestinal Scale for Gas and Bloating
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Chronic Pancreatitis
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
RecruitingObservational study
EUS Procedures Using RIVOS™ EUS Access Device
Pancreatic Fluid Collections, Biliary Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna E Phillips, MD MS principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pancreatic Enzyme Replacement Therapy, MBT1 and MBT 2 in people with Chronic Pancreatitis and Recurrent Acute Pancreatitis, run by Anna Evans Phillips at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna E Phillips, MD MS (412-864-7096, Evansac3@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (Aim 1) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.