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Evaluation of the efficacy of topical treatment with budesonide in children with Crohn's disease located in the esophagus and/or stomach and/or duodenum - BETHESDa
EU CTIS ID: 2024-519269-23-00
What this study is testing
THE OBJECTIVE OF THE STUDY IS TO ASSESS THE EFFECTIVENESS OF TOPICALLY APPLIED BUDESONIDE IN THE TREATMENT OF INFLAMMATIVE LEASES IN THE OESPHAGOM AND/OR THE GASTRIC AND/OR THE DUDENUM IN CHILDREN WITH LEŚNIOWSKI-CROHN'S DISEASE
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age 6-18
- CD diagnosed according to commonly accepted criteria from Porto, taking into account clinical, endoscopic and histopathological criteria; inflammatory changes in the esophagus and/or stomach and/or duodenum found in an endoscopic examination (assessed by 2 independent endoscopists) and confirmed in a histopathological examination (on the Paris scale CD-C activity: L4a, i.e. involvement of the upper gastrointestinal tract to the Treitz ligament)
- stable, understood as no treatment modification, CD treatment for ≥2 weeks; exclusion of causes of inflammatory changes in the esophagus and/or stomach and/or duodenum other than CD, such as: reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, Helicobacter pylori infection
- informed consent of the child's parents or guardians to participate in the study; for children ≥ 16 years of age additionally, the consent of the child participating in the study declaration of sexual abstinence during the entire participation in the study
- declaration of sexual abstinence during the entire participation in the study
You likely can't join if
- age <6 years or >18 years of age
- breastfeeding;
- lack of consent of a woman of reproductive age or a fertile man to follow contraceptive recommendations during the examination;
- the patient has had cancer
- other causes of inflammatory changes in the esophagus and/or stomach and/or duodenum, other than CD, such as reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, infection Helicobacter pylori;
- use of general steroids up to 30 days prior to study entry
See the full eligibility criteria
- age 6-18
- CD diagnosed according to commonly accepted criteria from Porto, taking into account clinical, endoscopic and histopathological criteria; inflammatory changes in the esophagus and/or stomach and/or duodenum found in an endoscopic examination (assessed by 2 independent endoscopists) and confirmed in a histopathological examination (on the Paris scale CD-C activity: L4a, i.e. involvement of the upper gastrointestinal tract to the Treitz ligament)
- stable, understood as no treatment modification, CD treatment for ≥2 weeks; exclusion of causes of inflammatory changes in the esophagus and/or stomach and/or duodenum other than CD, such as: reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, Helicobacter pylori infection
- informed consent of the child's parents or guardians to participate in the study; for children ≥ 16 years of age additionally, the consent of the child participating in the study declaration of sexual abstinence during the entire participation in the study
- declaration of sexual abstinence during the entire participation in the study
- age <6 years or >18 years of age
- breastfeeding;
- lack of consent of a woman of reproductive age or a fertile man to follow contraceptive recommendations during the examination;
- the patient has had cancer
- other causes of inflammatory changes in the esophagus and/or stomach and/or duodenum, other than CD, such as reflux esophagitis, esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastroduodenitis, infection Helicobacter pylori;
- use of general steroids up to 30 days prior to study entry
- use of inhaled steroids up to 30 days prior to study entry;
- PPI use up to 30 days prior to study entry;
- acute viral or bacterial infection up to 30 days prior to study entry;
- morning cortisol <5 ug/dL;
- lack of informed consent of the child's parents or guardians to participate in the study; for children ≥16 years of age lack of consent of the child to participate in the study.
- patient's pregnancy;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.