Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Poznan, Poland
Not recruiting
Study on the Effectiveness of Budesonide and Omeprazole for Treating Crohn's Disease in the Esophagus, Stomach, or Duodenum in Children
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on evaluating a treatment for in children. Crohn's disease is a condition that causes inflammation in the digestive tract. In this study, the treatment being tested is a medication called , which is applied directly to the affected areas. Budesonide is a type of medication known as a glucocorticoid, which helps reduce inflammation. The study aims to assess how effective budesonide is in treating inflammation in the esophagus, stomach, and duodenum, which are parts of the upper digestive tract.
Participants in the study will receive treatment with budesonide over a period of several weeks. The study will monitor changes in the inflammation of the esophagus, stomach, and duodenum through medical examinations. The goal is to see if the treatment can reduce or eliminate the signs of inflammation in these areas. Additionally, the study will observe any changes in the symptoms of Crohn's disease and assess the overall tolerance of the treatment by the participants.
Another medication involved in the study is , which is a proton pump inhibitor. This type of medication is often used to reduce stomach acid and is included in the study to support the treatment process. The study will last for a set period, and participants will be regularly monitored to ensure their safety and to evaluate the effectiveness of the treatment. The ultimate aim is to find a reliable treatment option for children suffering from Crohn's disease affecting the upper digestive tract.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- Children must be between the ages of 6 and 18.
- The child must have been diagnosed with **Crohn's disease**. This diagnosis should be based on widely accepted criteria, which include clinical symptoms, endoscopic examination (a procedure where a small camera is used to look inside the digestive tract), and histopathological examination (looking at tissue samples under a microscope).
- There must be inflammatory changes in the esophagus (the tube that carries food from the mouth to the stomach), stomach, or duodenum (the first part of the small intestine) found during an endoscopic examination and confirmed by a histopathological examination.
- The child's **Crohn's disease** treatment should be stable, meaning there have been no changes in treatment for at least 2 weeks.
- Other causes of inflammation in the esophagus, stomach, or duodenum must be ruled out. These include conditions like reflux esophagitis (inflammation due to acid reflux), esophagitis herpetiformis (inflammation due to herpes virus), cytomegalovirus esophagitis (inflammation due to cytomegalovirus), eosinophilic esophagitis (inflammation due to a high number of a type of white blood cell), and **Helicobacter pylori** infection (a type of bacteria that can cause stomach problems).
- The parents or guardians of the child must give informed consent for the child to participate in the study. If the child is 16 years or older, the child must also give their consent.
- There must be a declaration of sexual abstinence (not engaging in sexual activity) during the entire time the child is participating in the study.
Who cannot join the trial?
7 criteria
- Patients who do not have a diagnosis of Crohn's disease cannot participate. Crohn's disease is a condition that causes inflammation in parts of the digestive system.
- Children who are not within the specified age range for the study cannot participate. The study is for children, so adults are excluded.
- Patients who have other medical conditions that might interfere with the study cannot participate. This is to ensure the study results are accurate and not affected by other health issues.
- Patients who are unable to follow the study procedures or take the study medication as directed cannot participate. This is important for the safety and effectiveness of the study.
- Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different study treatments.
- Patients who have had a recent surgery or medical procedure that might affect the study cannot participate. This is to ensure the study results are not influenced by recent medical interventions.
- Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and baby.
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Verified sites
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Verified Verified Uniwersytecki Szpital Dzieciecy W Krakowie
Cracow, Poland
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Investigated drugs
Budesonide is a medication used in this clinical trial to treat inflammation in children with Crohn's disease. It is applied topically, meaning it is used directly on the affected areas in the esophagus, stomach, or duodenum. The goal of using budesonide in this study is to evaluate its effectiveness in reducing inflammation and improving symptoms in these specific areas of the digestive tract.
What is already known about the treatment
Budesonide – Budesonide is administered topically, often in the form of a liquid or foam, and is applied directly to the affected areas in the esophagus, stomach, or duodenum. It is currently being studied for its effectiveness in treating Crohn's disease, particularly in children with inflammation in these specific areas. The main therapeutic indication for budesonide in this context is to reduce inflammation associated with Crohn's disease. At the molecular level, budesonide works by binding to glucocorticoid receptors, which helps to decrease the production of inflammatory substances in the body. It is classified pharmacologically as a corticosteroid, known for its anti-inflammatory properties.
Investigated diseases
Crohn's disease – Crohn's disease is a chronic inflammatory condition that primarily affects the gastrointestinal tract. It can involve any part of the digestive system, from the mouth to the anus, but most commonly affects the end of the small intestine and the beginning of the colon. The inflammation can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The disease often progresses with periods of remission and flare-ups, where symptoms can become more severe. Over time, the inflammation can cause complications like strictures, fistulas, and malnutrition. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-519269-23-00Protocol codeBETHESDaCDEstimated enrolment138 patientsSponsorMedical University Of Warsaw
sourced from the EU Clinical Trials Register and site verification
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