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Study on the Use of Viscous Budesonide for Children with Eosinophilic Esophagitis

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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 studying Eosinophilic Esophagitis, a condition where a type of white blood cell called eosinophils builds up in the esophagus, causing inflammation and difficulty swallowing. The study will use a new formulation of a medication called Budesonide, which is a type of cortisone-like medicine. Budesonide will be prepared in a special way to make it more effective for this condition.

The purpose of the study is to evaluate how well this new viscous form of Budesonide works in children and adolescents with Eosinophilic Esophagitis. Participants will receive the medication in a liquid form that they will swallow. The study will last for about 12 weeks, during which the effects of the medication on the esophagus will be monitored. This includes checking if the number of eosinophils in the esophagus decreases and if symptoms improve.

Throughout the study, researchers will also keep track of any side effects or adverse events that participants might experience. The goal is to see if this new formulation of Budesonide can effectively reduce the symptoms and inflammation associated with Eosinophilic Esophagitis in young patients.

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
Joining the study
Upon joining the study, you will be asked to provide written consent from your parent or legal representative. If you are mature enough, you will also give verbal consent.
If you are a female of childbearing age, a urine pregnancy test will be conducted. You will need to use an acceptable method of contraception during the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and ensuring you meet the criteria for the study.
You must be between 4 and 18 years old and have a confirmed diagnosis of eosinophilic esophagitis (EoE) with specific conditions related to previous treatments.
Step 3
Medication administration
You will receive a new formulation of budesonide in a viscous suspension form. This medication is taken orally.
The dosage, frequency, and duration of administration will be explained to you by the study team. It is important to follow these instructions carefully.
Step 4
Monitoring and follow-up
Throughout the study, your health and response to the medication will be monitored. This includes regular check-ups and assessments.
At specific time points, such as T6 and T12, your symptoms and any side effects will be evaluated. This helps in understanding the effectiveness of the treatment.
Step 5
End of study evaluation
At the end of the study, a final evaluation will be conducted. This includes assessing the reduction or disappearance of eosinophils in the esophageal tissue.
Your overall experience and any changes in symptoms will be reviewed to determine the success of the treatment.

Who can join the trial?

6 criteria

Age between 4 and 18 years old.
Must have a diagnosis of Eosinophilic Esophagitis (EoE). This means having more than 15 eosinophils (a type of white blood cell) per high power field (HPF) in esophageal biopsies. The diagnosis should be confirmed by a procedure called endoscopy, which involves taking small tissue samples from the esophagus, stomach, and duodenum (the first part of the small intestine).
Should not have responded to treatment with proton pump inhibitors (medications that reduce stomach acid) or have experienced a flare-up after stopping these medications.
Can have had previous treatment with topical steroids (medications applied directly to the esophagus) but did not respond or had a flare-up after stopping them.
Must have written consent from a parent or legal representative, and verbal consent from the child, depending on their maturity.
If female and of childbearing age, must have a negative urine pregnancy test. Must agree to use contraception during the study. Acceptable methods include combined low-dose oral hormonal contraceptives, male or female condoms with or without spermicide, or a combination of these methods (known as double barrier methods).

Who cannot join the trial?

9 criteria

Patients who do not have a diagnosis of Eosinophilic Esophagitis cannot participate. This is a condition where a type of white blood cell called eosinophil builds up in the esophagus, which is the tube that connects the mouth to the stomach.
Patients who are not within the age range of 2 to 18 years old cannot participate.
Patients who are not able to swallow the study medication cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent surgery or are planning to have surgery during the study period cannot participate.
Patients who are allergic to any of the ingredients in the study medication cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of non-compliance with medical treatments cannot participate.

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Verified sites

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Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy

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Investigated drugs

Budesonide is a medication used in this clinical trial. It is a type of steroid that helps reduce inflammation in the body. In this study, a new form of budesonide is being tested, which is designed to be thicker and stickier. This special formulation is meant to help the medication stay in the esophagus longer, which may improve its effectiveness in treating Eosinophilic Esophagitis (EoE) in children and adolescents. EoE is a condition where the esophagus becomes inflamed due to an allergic reaction, and budesonide aims to reduce this inflammation and help relieve symptoms.

Budesonide

What is already known about the treatment

Budesonide Viscous Suspension – This medication is administered orally in the form of a thick liquid, designed to coat the esophagus. It is currently being studied in clinical trials for its effectiveness in treating Eosinophilic Esophagitis, a condition where white blood cells build up in the esophagus, causing inflammation and difficulty swallowing. Budesonide works by reducing inflammation at the molecular level, helping to alleviate symptoms. It is classified as a corticosteroid, a type of drug that mimics hormones produced by the adrenal glands to reduce inflammation and suppress the immune system.

Investigated diseases

Eosinophilic Esophagitis – Eosinophilic Esophagitis is a chronic immune system disease where a type of white blood cell, called eosinophil, builds up in the lining of the esophagus. This accumulation is often a reaction to foods, allergens, or acid reflux and can lead to inflammation. Over time, the inflammation can cause the esophagus to become stiff and narrow, making it difficult to swallow. Symptoms may include difficulty swallowing, food getting stuck in the esophagus, and chest pain that is not related to heart problems. The disease can affect both children and adults, and its symptoms can vary depending on age. If left unchecked, it can lead to complications such as esophageal narrowing or strictures.