Not recruiting

Study on the Effect of Pancreatic Enzyme Replacement Therapy with Pancreas Powder in Patients with Pancreatic Exocrine Insufficiency After Total Gastrectomy

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Pancreatic Enzyme Replacement Therapy (PERT) using Creon® 25000 Capsules in patients who have developed Pancreatic Exocrine Insufficiency (PEI) after undergoing a total gastrectomy. A total gastrectomy is a surgical procedure where the entire stomach is removed, which can lead to PEI, a condition where the pancreas does not produce enough enzymes to help digest food properly.

The purpose of this study is to evaluate how Creon affects the nutritional status of patients with PEI following their surgery. Participants in the study will take Creon capsules orally. The study will monitor the patients over a period to see if their nutritional status remains stable, particularly looking at whether there is any loss of body weight from the start of the study. Other aspects being observed include changes in body weight, symptoms of PEI, nutritional parameters, and overall quality of life related to gastrointestinal health.

Throughout the study, participants will be asked to keep diaries to record any symptoms they experience. The study will also track any side effects that may arise from the treatment, as well as changes in vital signs. The goal is to gather information on how effective Creon is in managing the symptoms of PEI and maintaining the nutritional health of patients who have had a total gastrectomy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Participants aged 18 to 80 who have undergone total gastrectomy and have pancreatic exocrine insufficiency (PEI) are eligible to join the study.
Participants must provide written informed consent and agree to follow the study protocol.
Step 2
Treatment initiation
Participants will begin taking Creon® 25000 Capsules, which contain pancreas powder.
The medication is taken orally in the form of capsules.
Step 3
Treatment phase
Participants will continue taking the prescribed dose of Creon® to manage symptoms of PEI.
The primary goal is to maintain nutritional status without weight loss from the baseline visit.
Step 4
Monitoring and assessment
Participants' body weight and nutritional parameters will be monitored regularly.
Participants will complete the Gastrointestinal Quality of Life Index (GIQLI) questionnaire to assess their quality of life.
Any symptoms of PEI and treatment emergent adverse events (TEAEs) will be recorded in subject diaries.
Step 5
Completion
The study is expected to conclude by June 30, 2026.
The final assessment will determine the proportion of patients who maintained their nutritional status and any changes in body weight from the baseline.

Who can join the trial?

8 criteria

Both male and female participants can join, regardless of their ethnic background.
Participants must be between the ages of 18 and 80, including those ages.
Participants should be willing to follow the study's rules and guidelines.
Participants need to provide written informed consent, which means they agree to join the study after understanding what it involves.
Participants must have had a total gastrectomy, which is a surgery where the stomach is completely removed.
Participants should have pancreatic exocrine insufficiency (PEI), a condition where the pancreas doesn't produce enough enzymes to help digest food. This should be shown by symptoms and confirmed with a fecal elastase test, a test that checks enzyme levels in stool.
Participants should not have received chemotherapy or radiotherapy in the week before joining the treatment phase of the study.
Participants should not have used any other investigational product in the three months before joining the treatment phase of the study. An investigational product is a drug or treatment that is being tested and is not yet approved for general use.

Who cannot join the trial?

4 criteria

Patients who have not had a **total gastrectomy**. This means the patient must have had their entire stomach surgically removed.
Patients younger than 18 years old or older than 80 years old.
Patients who do not have **PEI**. PEI stands for **Pancreatic Exocrine Insufficiency**, which is a condition where the pancreas does not produce enough enzymes to help digest food.
Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Creon is a medication used as pancreatic enzyme replacement therapy. It helps patients who have pancreatic exocrine insufficiency, a condition where the pancreas does not produce enough enzymes to properly digest food. This medication is particularly used in patients who have undergone a total gastrectomy, which is the surgical removal of the stomach. Creon aids in improving the nutritional status of these patients by helping them digest and absorb nutrients from their food.

Pancreas Powder

What is already known about the treatment

Creon – Creon is administered orally in the form of capsules and is used to help with digestion in people who have difficulty breaking down food due to a lack of pancreatic enzymes. It is currently recognized in medical literature as a treatment for Pancreatic Exocrine Insufficiency (PEI), particularly in patients who have undergone total gastrectomy. The main therapeutic indication for Creon is to improve nutritional absorption by supplementing the body's natural digestive enzymes. At the molecular level, Creon works by providing a mix of digestive enzymes, including lipase, protease, and amylase, which help break down fats, proteins, and carbohydrates, respectively. It is classified pharmacologically as a pancreatic enzyme replacement therapy.

Investigated diseases

Pancreatic Exocrine Insufficiency – This condition occurs when the pancreas does not produce enough enzymes to properly digest food. It often develops after surgical procedures like gastrectomy, where part or all of the stomach is removed. As a result, individuals may experience symptoms such as weight loss, diarrhea, and malnutrition due to poor absorption of nutrients. The condition can lead to a decrease in the quality of life, as it affects the digestive process and overall nutritional status. Monitoring and managing dietary intake are crucial to address the symptoms and maintain health.