Crohn Disease (CD)Phase 2/3BETHESDa-CDNCT06719622
Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum
A Phase 2/3 study testing budesonide and omeprazole (proton pump inhibitor) in people with Crohn Disease (CD), run by Medical University of Warsaw at 3 sites in Poland.
Trial summary
Crohn's disease (CD) is an inflammatory bowel disease characterized by chronic symptoms that include periods of exacerbation and remission. The exact cause of CD is not fully understood, but it is believed to result from a combination of genetic predispositions, immunological disorders, and environmental factors. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- budesonide and omeprazole (proton pump inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesPoland
- Study dates
- 30 Jul 2024to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CD diagnosed according to the commonly accepted Porto criteria, which take into account clinical, endoscopic and histopathological criteria;
- inflammatory changes in the esophagus and/or stomach and/or duodenum found in the endoscopic examination (assessed by 2 independent endoscopists) and confirmed in the histopathological examination (in the Paris scale, CD activity: L4a, i.e. involvement of the upper gastrointestinal tract up to the ligament of Treitz);
- stable, understood as no treatment modification, CD treatment for ≥2 weeks.
Who cannot join
- other than CD, causes of inflammatory changes in the esophagus and/or stomach and/or duodenum such as: reflux esophagitis, herpetic esophagitis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastritis and/or duodenitis, Helicobacter pylori infection;
- use of systemic steroids for up to 30 days before enrollment in the study;
- use of inhaled steroids for up to 30 days before enrollment in the study;
- use of IPP for up to 30 days before enrollment in the study;
- acute viral or bacterial infection for up to 30 days before enrollment in the study;
- morning cortisol <5 ug/dl;
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- lack of informed consent from the child's parents or guardians to participate in the study; in the case of children ≥16 years of age, lack of the child's consent to participate in the study.
- pregnancy
- breastfeeding;
- lack of consent of a woman of childbearing age or a fertile man to follow contraceptive recommendations during the study;
- history of cancer in the patient.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland3 sites
Jagiellonian University
Krakow, 30-663
Poznań University of Medical Sciences
Poznan, 60-572
Medical University of Warsaw
Warsaw, 02-091
About this study
Crohn's disease (CD) is an inflammatory bowel disease characterized by chronic symptoms that include periods of exacerbation and remission. The exact cause of CD is not fully understood, but it is believed to result from a combination of genetic predispositions, immunological disorders, and environmental factors. The incidence of CD is on the rise, particularly among children, with estimates suggesting that it affects 1 in 500 people in Western Europe and North America. Notably, one in four patients diagnosed with CD are children. The inflammatory changes associated with CD can affect the entire thickness of the gastrointestinal wall and can occur anywhere along the gastrointestinal tract, from the mouth to the anus. Persistent inflammation in the gastrointestinal tract increases the risk of cancer, which is already heightened in patients with CD. In the pediatric population, inflammation in the esophagus, stomach, and duodenum is present in about 30% of cases and is associated with a poorer prognosis. Another factor linked to a worse prognosis is the age at diagnosis; younger patients tend to have a more severe disease course. Therefore, all children with CD generally experience a worse prognosis compared to adults. The treatment of CD is life-lasting and often challenging. It includes dietary modifications, pharmacological interventions, and sometimes surgical procedures, depending on the disease's activity and the location of the inflammation. The pharmacological treatment typically involves several types of medications: 5-ASA preparations, immunomodulatory drugs, biological drugs and local treatments such as suppositories, enemas and prolonged-release capsules. The most effective treatment approaches combine both systemic and local medications targeted at the affected areas of the intestine. In local treatment for CD, budesonide plays a crucial role. This corticosteroid has a strong anti-inflammatory effect and is characterized by low bioavailability, with 90% of the drug metabolized in the liver. Consequently, only 10% reaches the systemic circulation, minimizing the potential for adverse effects. Currently, budesonide is used to treat inflammatory changes in the distal small intestine (via sustained-release or enteric-coated capsules), rectum, and sigmoid colon (as rectal foam), or in the large intestine (with multimatrix tablets). Unfortunately, there is no local treatment available for patients with CD who have inflammation in the esophagus, stomach, or duodenum. Recommendations often suggest the use of antacids, such as proton pump inhibitors, which typically alleviate symptoms but do not promote remission of the inflammation. Given this gap in treatment, it has been hypothesized that adding locally acting budesonide to systemic therapy could be effective for children with inflammatory changes in the esophagus, stomach, and/or duodenum associated with CD. The aim of this study is to assess the efficacy of locally applied budesonide in treating these specific inflammatory changes in pediatric patients with Crohn's disease.
Read the detailed description
The prospective, randomized, single-blind study. Children with CD who meet the inclusion criteria will be randomly assigned, based on a computer-generated randomization list, to one of two groups. One group will be treated with budesonide and the other with omeprazole. All preparations will be taken orally by children every 12 hours for 8 weeks. The child will swallow the capsule/capsules (with omeprazole) with water or the content of the ampoule/ampoules (budesonide). For 30 minutes after swallowing each dose, the patient will not drink, eat, chew gum or brush their teeth. After 30 minutes, the patient will be asked to rinse their mouth. The expected time from the start of screening to randomization is 2 weeks. Follow-up visits will take place at weeks 4, 8, and 12 of the study. The permitted deviation from the designated checkpoints (including randomization) is +/- 4 days. At the visit after 8 weeks, a control gastroscopy will be performed with collection of samples for histopathological evaluation. The 12-week visit will be a follow-up check
- Conditions
- Crohn Disease (CD)
- Being tested
- budesonide, omeprazole (proton pump inhibitor)
- Keywords
- children, esophagus, upper digestive tract, duodenum, stomach, pediatrics, gastroscopy, gastrointestinal endoscopy, local treatment, glucocorticosteroids, omeprazole, proton pump inhibitor
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
1 mg budesonide ampoule twice daily for patients weighing ≤35 kg or 2 mg twice daily for patients weighing >35 kg
omeprazole (proton pump inhibitor)Drug
omeprazole 10 mg twice daily for patients weighing ≤35 kg or 20 mg twice daily for patients weighing >35 kg
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Experimental | Not described Receives: Drug: budesonide |
| Omeprazole | Active comparator | Not described Receives: Drug: omeprazole (proton pump inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
the percentage of patients with no endoscopic and histopathological changes in the esophagus, stomach and duodenum
Measured: 8 weeks
Secondary outcomes (6)
Endoscopic effectiveness
the percentage of patients with no endoscopic changes in the esophagus, stomach and duodenum, respectively (which were present at the time of study entry)
Measured: 8 weeks
Histopathological effectiveness
the percentage of patients with no histopathological changes in the esophagus, stomach and duodenum, respectively
Measured: 8 weeks
Disease activity
disease activity assessed on the Pediatric Crohn Disease Activity Index scale
Measured: 8 weeks
Symptoms resolution
the percentage of patients who had resolution of upper gastrointestinal symptoms
Measured: 4, 8 and 12 week
Adverse reactions
the percentage of patients with adverse steroid reactions
Measured: 4, 8 and 12 week
Toleranc
treatment tolerance assessment on a 10-point VAS scale
Measured: 4 and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start30 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, Poznan University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719622
- Sponsor's protocol ID
- ABM01
- Acronym
- BETHESDa-CD
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum
- ClinicalTrials.gov ID
- NCT06719622
- Acronym / sponsor ID
- BETHESDa-CD / ABM01
- Conditions
- Crohn Disease (CD)
- Keywords
- children, esophagus, upper digestive tract, duodenum, stomach, pediatrics, gastroscopy, gastrointestinal endoscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Jagiellonian University, Poznan University of Medical Sciences
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crohn's disease (CD) is an inflammatory bowel disease characterized by chronic symptoms that include periods of exacerbation and remission. The exact cause of CD is not fully understood, but it is believed to result from a combination of genetic predispositions, immunological disorders, and environmental factors. The incidence of CD is on the rise, particularly among children, with estimates suggesting that it affects 1 in 500 people in Western Europe and North America. Notably, one in four patients diagnosed with CD are children. The inflammatory changes associated with CD can affect the entire thickness of the gastrointestinal wall and can occur anywhere along the gastrointestinal tract, from the mouth to the anus. Persistent inflammation in the gastrointestinal tract increases the risk of cancer, which is already heightened in patients with CD. In the pediatric population, inflammation in the esophagus, stomach, and duodenum is present in about 30% of cases and is associated with a poorer prognosis. Another factor linked to a worse prognosis is the age at diagnosis; younger patients tend to have a more severe disease course. Therefore, all children with CD generally experience a worse prognosis compared to adults. The treatment of CD is life-lasting and often challenging. It includes dietary modifications, pharmacological interventions, and sometimes surgical procedures, depending on the disease's activity and the location of the inflammation. The pharmacological treatment typically involves several types of medications: 5-ASA preparations, immunomodulatory drugs, biological drugs and local treatments such as suppositories, enemas and prolonged-release capsules. The most effective treatment approaches combine both systemic and local medications targeted at the affected areas of the intestine. In local treatment for CD, budesonide plays a crucial role. This corticosteroid has a strong anti-inflammatory effect and is characterized by low bioavailability, with 90% of the drug metabolized in the liver. Consequently, only 10% reaches the systemic circulation, minimizing the potential for adverse effects. Currently, budesonide is used to treat inflammatory changes in the distal small intestine (via sustained-release or enteric-coated capsules), rectum, and sigmoid colon (as rectal foam), or in the large intestine (with multimatrix tablets). Unfortunately, there is no local treatment available for patients with CD who have inflammation in the esophagus, stomach, or duodenum. Recommendations often suggest the use of antacids, such as proton pump inhibitors, which typically alleviate symptoms but do not promote remission of the inflammation. Given this gap in treatment, it has been hypothesized that adding locally acting budesonide to systemic therapy could be effective for children with inflammatory changes in the esophagus, stomach, and/or duodenum associated with CD. The aim of this study is to assess the efficacy of locally applied budesonide in treating these specific inflammatory changes in pediatric patients with Crohn's disease.
Detailed description
The prospective, randomized, single-blind study. Children with CD who meet the inclusion criteria will be randomly assigned, based on a computer-generated randomization list, to one of two groups. One group will be treated with budesonide and the other with omeprazole. All preparations will be taken orally by children every 12 hours for 8 weeks. The child will swallow the capsule/capsules (with omeprazole) with water or the content of the ampoule/ampoules (budesonide). For 30 minutes after swallowing each dose, the patient will not drink, eat, chew gum or brush their teeth. After 30 minutes, the patient will be asked to rinse their mouth. The expected time from the start of screening to randomization is 2 weeks. Follow-up visits will take place at weeks 4, 8, and 12 of the study. The permitted deviation from the designated checkpoints (including randomization) is +/- 4 days. At the visit after 8 weeks, a control gastroscopy will be performed with collection of samples for histopathological evaluation. The 12-week visit will be a follow-up check
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Experimental | Drug: budesonide |
| Omeprazole | Active comparator | Drug: omeprazole (proton pump inhibitor) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- CD diagnosed according to the commonly accepted Porto criteria, which take into account clinical, endoscopic and histopathological criteria;
- inflammatory changes in the esophagus and/or stomach and/or duodenum found in the endoscopic examination (assessed by 2 independent endoscopists) and confirmed in the histopathological examination (in the Paris scale, CD activity: L4a, i.e. involvement of the upper gastrointestinal tract up to the ligament of Treitz);
- stable, understood as no treatment modification, CD treatment for ≥2 weeks.
Key exclusion criteria (11 listed)
- other than CD, causes of inflammatory changes in the esophagus and/or stomach and/or duodenum such as: reflux esophagitis, herpetic esophagitis, cytomegalovirus esophagitis, eosinophilic esophagitis and/or gastritis and/or duodenitis, Helicobacter pylori infection;
- use of systemic steroids for up to 30 days before enrollment in the study;
- use of inhaled steroids for up to 30 days before enrollment in the study;
- use of IPP for up to 30 days before enrollment in the study;
- acute viral or bacterial infection for up to 30 days before enrollment in the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide1 mg budesonide ampoule twice daily for patients weighing ≤35 kg or 2 mg twice daily for patients weighing >35 kg | Drug | Budesonide |
| omeprazole (proton pump inhibitor)omeprazole 10 mg twice daily for patients weighing ≤35 kg or 20 mg twice daily for patients weighing >35 kg | Drug | Omeprazole |
Primary outcome
Effectiveness
Time frame: 8 weeks
the percentage of patients with no endoscopic and histopathological changes in the esophagus, stomach and duodenum
6 secondary outcomes
Endoscopic effectiveness
Time frame: 8 weeks
Histopathological effectiveness
Time frame: 8 weeks
Disease activity
Time frame: 8 weeks
Symptoms resolution
Time frame: 4, 8 and 12 week
Adverse reactions
Time frame: 4, 8 and 12 week
Toleranc
Time frame: 4 and 8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing budesonide and omeprazole (proton pump inhibitor) in people with Crohn Disease (CD), run by Medical University of Warsaw at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.