Clinical trials: Exocrine Pancreatic Insufficiency
Cystic Fibrosis, Cystic Fibrosis Gastrointestinal Disease
Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs
This is a Phase 2 study sponsored by AzurRx SAS and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF).
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Gastrointestinal Disease, Cystic Fibrosis of Pancreas
- Trial name
- NCT04302662
- Testing
- MS1819-SD
- Where
- 10 sites in Hungary, Turkey (Türkiye)
- Volunteers
- 20 people
- Sponsor
- AzurRx SAS
Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients with Type 2 diabetes mellitus (T2DM), and to…
- Trial name
- PRECISE (NCT02370537)
- Testing
- Epanova® (omega-3 carboxylic acids), Omacor® (omega-3-acid ethyl esters)
- Where
- 22 sites in Denmark, Hungary and 4 more
- Volunteers
- 490 people
- Sponsor
- AstraZeneca
Bone Marrow Failure Syndrome, Severe Aplastic Anemia
CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation
This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the…
- Conditions
- Bone Marrow Failure Syndrome, Severe Aplastic Anemia, Severe Congenital Neutropenia, Amegakaryocytic Thrombocytopenia
- Trial name
- NCT01966367
- Testing
- CD34 Stem Cell Selection Therapy
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Diane George
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00981214
- Testing
- EUR-1008 (APT-1008)
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Forest Laboratories
Dyskeratosis Congenita, Fanconi Anemia
Assessing Immune Function in Young Patients With Cytopenia That Did Not Respond to Treatment
RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that did not respond to treatment may help doctors learn more about the disease and plan the best treatment.
- Conditions
- Dyskeratosis Congenita, Fanconi Anemia, Myelodysplastic Syndromes, Pearson Marrow-pancreas Syndrome
- Trial name
- NCT00499070
- Testing
- polymerase chain reaction, flow cytometry, immunologic technique
- Where
- 10 sites in Austria, Belgium and 8 more
- Volunteers
- 119 people
- Sponsor
- University Hospital Freiburg
Exocrine Pancreatic Insufficiency
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI.
- Trial name
- NCT00559052
- Testing
- VIOKASE 16
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Axcan Pharma
Fibrosing Colonopathy
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of…
- Trial name
- NCT01652157
- Testing
- ULTRESA, PANCREAZE, CREON
- Where
- 123 sites in United States
- Volunteers
- 17 people
- Sponsor
- AbbVie
Irritable Bowel Syndrome
Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment.
- Trial name
- NCT01641341
- Testing
- Bifidobacterium infantis, Pancrelipase, Nitazoxanide
- Where
- 9 sites in United States
- Volunteers
- 61 people
- Sponsor
- American Academy of Family Physicians
Pancreatic Insufficiency
Creon After Pancreatic Surgery
This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA
- Trial name
- NCT00535756
- Testing
- Creon
- Where
- 15 sites in Bulgaria, Germany and 2 more
- Volunteers
- 58 people
- Sponsor
- Abbott Products
Critically Ill, Enteral Feeding
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.
- Conditions
- Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency
- Trial name
- PREZENT (NCT05112328)
- Testing
- Exocrine Pancreatic Enzyme
- Where
- South Korea
- Volunteers
- 170 people
- Sponsor
- Seoul National University Hospital
Pancreatic Exocrine Insufficiency
PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency
The aim of this study was to evaluate and determine the clinical performance of Fecal Pancreatic Elastase 1 Test in the diagnosis of pancreatic exocrine insufficiency.
- Trial name
- NCT05791110
- Testing
- Fecal pancreatic elastase 1 test
- Where
- China
- Volunteers
- 1,053 people, healthy volunteers welcome
- Sponsor
- Changhai Hospital
Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM)
Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes
The goal of this observational study is to better understand how the pancreas works in adults with type 2 diabetes. The study focuses on both hormone production (endocrine function) and digestive function (exocrine function) of…
- Conditions
- Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Exocrine Pancreatic Insufficiency (EPI)
- Trial name
- T3cDM-AKT (NCT07512934)
- Where
- Kazakhstan
- Volunteers
- 310 people
- Sponsor
- West Kazakhstan Marat Ospanov Medical University
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional…
- Trial name
- NCT04966897
- Testing
- Standard Nutritional Supplement + PERT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- GlycosBio, Inc.
Chronic Pancreatitis, Pancreatic Exocrine Insufficiency
Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
The goal of this observational study is to improve the epidemiological data of pancreatic exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of PEI, and explore the characteristic differences…
- Conditions
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency, Diabetes Mellitus, Community Populations
- Trial name
- NCT06006312
- Testing
- fecal elastase-1 test, 72-hour fecal fat quantification, blood sample test
- Where
- China
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Changhai Hospital
Pancreatic Exocrine Insufficiency
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
- Trial name
- NCT01747330
- Testing
- Pancreatin
- Where
- 9 sites in Russia
- Volunteers
- 40 people
- Sponsor
- Abbott Products
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP)…
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy
- Trial name
- NCT00559364
- Testing
- Viokase® 16, Proton pump inhibitor (PPI), Omeprazole
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Forest Laboratories
Sickle Cell Disease, Transfusion Dependent Alpha- or Beta- Thalassemia
Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies
This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.
- Conditions
- Sickle Cell Disease, Transfusion Dependent Alpha- or Beta- Thalassemia, Diamond Blackfan Anemia, Paroxysmal Nocturnal Hemoglobinuria
- Trial name
- NCT02179359
- Testing
- Reduced Toxicity Ablative Regimen, Reduced Intensity Preparative Regimen, Myeloablative Preparative Regimen
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy
The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy
A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT).
- Conditions
- Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy, Pancreaticoduodenectomy
- Trial name
- NCT06119880
- Testing
- Pancreatin Enteric-coated Capsules, Routine treatment plan
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Ruijin Hospital
Diarrhea, Exocrine Pancreatic Insufficiency
Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
The prevalence of exocrine pancreatic insufficiency (EPI) among patients presenting with diarrhea and bloating as their chief complaints is not well studied.
- Conditions
- Diarrhea, Exocrine Pancreatic Insufficiency, Abdominal Pain
- Trial name
- NCT03407534
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- Baylor College of Medicine
Type 1 Diabetes, Exocrine Pancreatic Insufficiency
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) and Exocrine Pancreatic Dysfunction in Type 1 Diabetes
This study proposes to examine the contribution of CFTR variants to exocrine pancreatic insufficiency and hypoglycemic risk. Hypoglycemia is one the most frequent complications of type 1 diabetes management.
- Trial name
- NCT05385211
- Testing
- Frequency of hypoglycemia in people with type 1 diabetes and exocrine pancreatic insufficiency
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Ciusss de L'Est de l'Île de Montréal