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

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What is this study about?

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.

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.

2 treatment initiation

Participants will begin taking Creon® 25000 Capsules, which contain pancreas powder.

The medication is taken orally in the form of capsules.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Unidade Local De Saude Do Alto Minho E.P.E.	Ponte De Lima	Portugal
Szpital Miejski Specjalistyczny Im. Gabriela Narutowicza W Krakowie	Cracow	Poland
Fwipnl 2 Sfv z ooue	Oświęcim	Poland
Pocpterqy Immtfmzl Muakwyks Mwfeugnxpxxx Sqvir Wxrirsntqele I Axbdoohayukyh	Warsaw	Poland
Ndytclzo Iccjkzml Ooabrbtlx Irl Mxscy Scfqylvkacyhebvbdonwnxmusbvr Ihelccbg Btpxuahh	Cracow	Poland
Htsskdvt Ds Lg Sbifn Cgeb I Sqjp Pjt	Barcelona	Spain
Wtvpsupixq Sdxgwcz Icq Sveatgw Pzy W Psqrjeiot	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	27.09.2024
Portugal	Not recruiting	27.09.2024
Spain	Not recruiting	27.09.2024

Trial locations

Investigated drugs:

Pancreas Powder

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.

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.

Trial ID:

2023-507837-18-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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