Active clinical trials for "Exocrine Pancreatic Insufficiency"

Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. The study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.

Background: exocrine pancreatic insufficiency (IPE), frequent in patients with pancreatic cancer, plays a major role in malnutrition and cachexia with a significant impact on survival, quality of life and tumor progression. IPE due to obstruction of the main pancreatic duct and atrophy of pancreatic parenchyma proximal to the tumor could be corrected by insertion of a pancreatic stent for improving nutritional status and consequently survival. Aim: The aim of this study is to assess the impact of transpapilar drainage of the main pancreatic duct on exocrine pancreatic function, nutritional status, and life survival in patients with unresectable pancreatic adenocarcinoma. Methods: Impact of pancreatic endoscopic drainage on exocrine pancreatic function in patients with unresectable pancreatic adenocarcinoma (DEPARA) is a double-blind, prospective, multicentre, international clinical trial. Unresectable locally advanced or metastatic pancreatic cancer (PDAC) will be diagnosed according to the National Comprehensive Cancer Network (NCCN) criteria and the indication of endoscopic retrograde cholangiopancreatography (ERCP) due to obstructive jaundice (>3mg/dl). PEI will be defined by reduced fecal elastase levels. The nutritional status will be determined by means of Mini-Nutritional Assessment score, sarcopenia score (SARC-F) and laboratory blood tests. Primary aim: Evaluation of the improvement and difference of pancreatic secretion as measured by fecal elastase at 2 weeks post-stenting (biliopancreatic versus biliary). Secondary aims: evaluation of the prevalence of PEI post-stenting (biliopancreatic versus biliary) and proportion of patients normalizing pancreatic function. The difference in terms of weight loss, maldigestion symptoms, GI-Qol, nutricional status and performance status. Survival at 2 weeks, 3 and 6 months, overall survival. Analyzes: fecal elastase value at 2 weeks post-stenting (absolute value of fecal elastase) compared between biliopancreatic stent group and biliary stent group. Discussion: DEPARA will provide insight into the role of pancreatic stents for PEI, malnutrition and progression-free survival in the outcomes of PDAC unresectable.

Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis. The main question[s] the study aims to answer are: Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use. Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). PEI can be treated with oral pancreatic enzyme replacement therapy (PERT). However, the diagnosis of PEI is difficult and the guidelines about when to start PERT after pancreas surgery are conflicting. This pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting PERT immediately after surgery can improve outcomes in patients undergoing pancreas surgery.

This is a prospective randomized controlled trial. . Patients will be divided into conservative or endoscopic group and fecal pancreatic elastase-1 (FE-1) is tested to evaluate pancreatic exocrine function. The effect of extracorporeal shock wave lithotripsy and endoscopic treatment on the progression of chronic pancreatitis in painless patients will be determined.

Acute pancreatitis represents an acute inflammatory process of the pancreas, which undergoes local and systemic complications, associated with non-negligible morbidity and mortality, and significant economic and quality of life impact. Even after the recovery phase, the development and persistence of sequelae from the inflammatory/necrotic process, including exocrine and endocrine pancreatic insufficiencies, are frequent. Although well documented as consequence of other pancreatic conditions, exocrine pancreatic insufficiency (EPI) after acute pancreatitis is poorly studied and probably underdiagnosed. The prevalence, diagnosis, independent risk factors and therapeutic approaches for EPI after acute pancreatitis need further investigation. Recent evidence suggests the involvement of the pancreas-intestinal axis and immunological dysfunction in several pancreatic pathologies, although their role in the development of EPI after acute pancreatitis is still scarce. Pancreatic enzyme replacement therapy (PERT) is the only treatment currently available in EPI, but the timing for start and duration of this therapy in acute pancreatitis remain to be established. This study have the following objectives: to determine the prevalence, clinical, analytical and nutritional biomarkers and duration of EPI after acute pancreatitis, as well as changes in gut microbiota and immunologic response, and quality of life in EPI and response to PERT after acute pancreatitis; and to determine the prevalence and biomarkers associated with endocrine pancreatic insufficiency following acute pancreatitis and the presence of gut dysbiosis and immunologic changes in acute pancreatitis according to its severity.

This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.

DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.

In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear. The purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients. Enrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups: Cystic Fibrosis participants with normal glucose tolerance Non-Cystic Fibrosis controls

The objective of this study is to assess weight stability, functional changes, and quality of life when Pancreaze (pancrelipase) delayed-release 84,000-lipase units (capsules), for main meals, and 42,000-lipase units (capsules), for snacks, are added to standard of care in patients with exocrine pancreatic insufficiency due to pancreatic adenocarcinoma. This will be the first prospective study of this particular formulation in addition to standard of care in advanced pancreatic cancer patients. We will treat 45 consecutive patients with borderline resectable, locally advanced and advanced pancreatic cancer patients who present with weight loss and exocrine pancreatic insufficiency with this advanced formulation of Pancreaze.