EUCTR2022-003716-91-DERecruitingPhase 1
Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy with consideration of compliance and symptom burden in patients with gastroesophageal reflux disease (GERD). - CeGaBeGa
Centrum Gastroenterologie Bethanien0 sites60 target enrollmentStarted: December 20, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients of either sex aged = 18 years.
- •Outpatients with ongoing PPI therapy (due to GERD) whose ongoing PPI intake is to be discontinued (e.g., prior to a planned diagnostic procedure).
- •Signed consent to participate and to the collection and pseudonymized sharing of personal data.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •- Uncooperative patients
- •- Presence of red flag symptoms (dysphagia, anemia, weight loss in the past 3 months, recurrent bleeding, or recurrent vomiting)
- •- Presence of known Barrett's esophagus
- •History of surgery to the esophagus or stomach
- •Hypersensitivity to sodium alginate or potassium bicarbonate
- •Allergy to the sweetener saccharin (E954)
- •Allergy to spices, such as anise, mugwort, dill, fennel, carrot, coriander, cumin, paprika, parsley, celery and tomato
- •Existing alcohol abuse or abuse of medications or drugs.
- •Patients incapable of giving consent
- •Patients who do not have sufficient command of the German language (consent form)
- •Patients who are in a dependent relationship with the sponsor, investigator, other study personnel or the study center
Investigators
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