Clinical trials: Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants with EPI.
- Conditions
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF), Pancreatic Enzyme Abnormality, Pancreatic Diseases
- Trial name
- EPIC (NCT07559175)
- Testing
- NHS7108, Zenpep®
- Where
- 39 sites in United States, Bulgaria and 5 more
- Volunteers
- 66 people
- Sponsor
- Aimmune Nestlé Health Science US R&D, LLC
Cystic Fibrosis
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine…
- Trial name
- NCT03924947
- Testing
- Pancrelipase
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- AbbVie
Chronic Pancreatitis, Healthy Volunteers
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
- Trial name
- NCT01259544
- Testing
- benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
- Where
- India
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Chronic Pancreatitis, Exocrine Pancreatic Insufficiency
AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients
Early assessment of pancreatic exocrine insufficiency (PEI) is crucial for determining appropriate chronic pancreatitis (CP) treatment plans, thereby avoiding unnecessary suffering and further complications in patients.
- Conditions
- Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Machine Learning, Deep Learning
- Trial name
- NCT06278272
- Where
- China
- Volunteers
- 504 people
- Sponsor
- Changhai Hospital
Cystic Fibrosis, Liver Disease or Abnormalities
Diagnosis and Treatment of Patients With Cystic Fibrosis
This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural…
- Conditions
- Cystic Fibrosis, Liver Disease or Abnormalities, Diabetes, Pancreatic Insufficiency (Exocrine and Endocrine)
- Trial name
- NCT00001223
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Digestive System Diseases, Pancreatic Disease
Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients <= 2 years of age.
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Trial name
- NCT00663975
- Testing
- DCI 1020
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Digestive Care, Inc.
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00408317
- Testing
- Ultrase® MT20
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the…
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Trial name
- NCT01427712
- Testing
- Pancrelipase
- Where
- 21 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Mylan Inc.
Abdominal Pain, Irritable Bowel Syndrome
Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
This is a 3-year prospective study too identify the role of exocrine pancreatic insufficiency in patients with abdominal pain who are undergoing upper endoscopy.
- Trial name
- NCT04231279
- Testing
- synthetic human secretin
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Orlando Health, Inc.
Exocrine Pancreatic Insufficiency
BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).
- Trial name
- NCT04548778
- Testing
- BÜHLMANN fPELA assay
- Where
- Germany
- Volunteers
- 201 people
- Sponsor
- Bühlmann Laboratories AG
Critical Illness, Sepsis
Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Supplementation in Critically Ill Adult Patients
Malnutrition is a frequent problem in critically ill patients that is associated with detrimental clinical outcomes. To provide adequate nutritional support, current studies focused mostly on the choice of delivery timing…
- Conditions
- Critical Illness, Sepsis, Diabetes, Cardiac Arrest
- Trial name
- NCT01753024
- Testing
- Enteral nutrition (EN)
- Where
- 2 sites in China
- Volunteers
- 362 people
- Sponsor
- Shanghai 10th People's Hospital
Pancreatic Exocrine Insufficiency, Adul
A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based…
- Trial name
- NCT07751367
- Testing
- High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet, Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Cystic Fibrosis, Pancreatic Insufficiency
Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop.
- Trial name
- NCT01879228
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Pennsylvania
Shwachman-Diamond Syndrome, Shwachman-Diamond Syndrome-Like
Shwachman Diamond Syndrome Registry and Study
Shwachman-Diamond syndrome (SDS) is a genetic condition characterized by bone marrow failure, medical co-morbidities, and leukemia predisposition.
- Trial name
- SDSR (NCT06056908)
- Where
- 4 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Boston Children's Hospital
Exocrine Pancreatic Insufficiency, Pancreatic Diseases
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and…
- Conditions
- Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Trial name
- NCT01427725
- Testing
- Lipacreon
- Where
- 189 sites in Japan
- Volunteers
- 579 people
- Sponsor
- Mylan Inc.
Exocrine Pancreatic Insufficiency
Registry of Pancreatic Exocrine Insufficiency: Enzyme Dose Requirements and Outcomes in Pancreatic Exocrine Insufficiency Across Aetiologies
EURO-PEI is a multicentre, observational registry conducted at eight specialist pancreatic centres in Spain, Hungary, France, Italy, and the United Kingdom.
- Trial name
- EURO-PEI regis (NCT05450627)
- Testing
- Pancreatic Enzyme
- Where
- Spain
- Volunteers
- 1,015 people
- Sponsor
- Hospital Clinico Universitario de Santiago
Acute Pancreatitis
Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an…
- Trial name
- PAPPEI (NCT03063398)
- Testing
- No intervention, this is an observational study
- Where
- 3 sites in United States
- Volunteers
- 196 people
- Sponsor
- Ohio State University
Neutropenia
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are…
- Trial name
- NCT06056297
- Testing
- Mavorixafor
- Where
- 114 sites in United States, Argentina and 23 more
- Volunteers
- 176 people
- Sponsor
- X4 Pharmaceuticals
Cystic Fibrosis (CF), Chronic Kidney Disease(CKD)
Kidney Function in People With Cystic Fibrosis in the Era of HEMT
The purpose of this study is to find out what causes kidney disease in people with CF. The investigators will study biomarkers in the blood and urine that can either predict who is at risk or detect kidney damage early before it…
- Conditions
- Cystic Fibrosis (CF), Chronic Kidney Disease(CKD), Acute Kidney Injury
- Trial name
- NCT06595420
- Where
- 3 sites in United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Virginia