Malabsorption Blood Test for Chronic Pancreatitis

(MBT Trial)

This trial explores a new method to assist individuals with chronic or recurring pancreatitis. Researchers use a Malabsorption Blood Test (MBT) to determine if patients have pancreatic enzyme deficiencies. Participants who respond to pancreatic enzyme replacement therapy (PERT) will join a study to assess improvements in their quality of life. Ideal candidates have experienced at least two pancreatitis attacks and have shown normal fecal elastase levels within the past year. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research aims to understand its benefits for a broader patient population.

You may need to stop taking certain medications that affect fat absorption or are related to the study, like orlistat or GLP-1 Receptor Agonists. The trial protocol doesn't specify other medications, so it's best to discuss your current meds with the trial team.

Research has shown that pancreatic enzyme replacement therapy (PERT) is generally safe for most people with exocrine pancreatic insufficiency, a condition often linked to chronic pancreatitis. Studies have found that patients using PERT experience few side effects, which are usually mild. Common issues include stomach pain, bloating, and diarrhea, but these are typically manageable.

In a year-long study, patients with chronic pancreatitis using PERT did not report any serious side effects, indicating a strong safety record. Additionally, the FDA has approved PERT for treating exocrine pancreatic insufficiency, supporting its safety for human use.

Researchers are excited about this trial because it explores a new blood test method for diagnosing malabsorption in chronic pancreatitis patients, which is a significant advancement over traditional diagnostic methods. Unlike conventional approaches that often rely on invasive tests or symptom observation, this method offers a direct way to assess pancreatic enzyme activity. Additionally, the trial investigates the effectiveness of Pancreatic Enzyme Replacement Therapy (PERT) in varied sequences, potentially refining how we understand treatment timing and impact. This could lead to more personalized and effective management strategies for those suffering from chronic pancreatitis.

Research has shown that Pancreatic Enzyme Replacement Therapy (PERT), a treatment under study in this trial, effectively addresses symptoms of exocrine pancreatic insufficiency (EPI). EPI occurs when the pancreas fails to produce enough enzymes for digestion. Studies have found that PERT reduces symptoms such as stomach pain, gas, and changes in stool. It also enhances nutrition levels and improves the overall quality of life for individuals with chronic pancreatitis. PERT is considered safe and well-tolerated, with no major side effects reported in these studies. This therapy aids in the absorption of fats and proteins, a significant challenge for those with EPI.⁶⁷⁸⁹¹⁰