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New treatment option for Chronic Pancreatitis
Official title Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
ClinicalTrials.gov ID: NCT07418593
What this study is testing
What is Pancreatic Enzyme Replacement Therapy?
Pancreatic Enzyme Replacement Therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic pancreatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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...
- Fecal elastase ≥ 50 within the preceding 12 months
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.