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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 study about?

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.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 6 and 18 years and a diagnosis of Crohn’s disease affecting the esophagus, stomach, or duodenum.

The assessment involves clinical, endoscopic, and histopathological evaluations to confirm inflammatory changes in the specified areas.

2 medication administration

Participants receive omeprazole in the form of gastro-resistant capsules, taken orally. The dosage is 10 mg, but the frequency and duration are determined by the study protocol.

Additionally, budesonide is administered as a nebuliser suspension, also taken orally. The concentration is 0.50 mg/ml, with specific dosage and frequency outlined in the study protocol.

3 monitoring and evaluation

Participants undergo regular monitoring to assess the effectiveness of the treatment. This includes endoscopic and histopathological evaluations at specified intervals.

The primary goal is to determine the percentage of patients with no endoscopic and histopathological changes in the esophagus, stomach, or duodenum.

4 secondary assessments

Secondary assessments occur at the 4th, 8th, and 12th weeks. These include evaluating the disappearance of gastrointestinal symptoms and any adverse effects of steroids.

The Pediatric Crohn Disease Activity Index (PCDAI) is used to assess disease activity at the 8th week.

5 treatment tolerance

Participants’ tolerance to the treatment is assessed using a 10-point Visual Analogue Scale (VAS) at the 4th and 8th weeks.

6 completion

The study is estimated to conclude by February 28, 2027. Final evaluations are conducted to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie Warsaw Poland
Slrehck Ktzoqnfsm Ieg Kjsllx Jllizkjsz Ujhftudfixfo Mqzdspdeqi Iyn Kogasx Mbxlamqvkpmzksa W Peruyhmt Poznan Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.12.2021

Trial locations

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.

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 ID:
2024-519269-23-00
Protocol code:
BETHESDaCD
Trial Phase:
Therapeutic confirmatory (Phase III)

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