Carminal for H. pylori gastritis
Evaluation of the Efficacy of Carminal on the Gastric Mucosa in Patients With Helicobacter Pylori Positive Gastritis
This trial will test if taking 30 ml daily of the Aloe vera–based supplement Carminal together with standard H. pylori therapy helps adults with H. pylori–positive gastritis heal their stomach lining better than standard therapy plus placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catalysis SL Industry-sponsored |
| Locations | 2 sites (Belgrade, Central Serbia and 1 other locations) |
| Trial ID | NCT07179237 on ClinicalTrials.gov |
What this trial studies
Eighty adults with dyspepsia and histologically confirmed H. pylori gastritis will be randomized 1:1 to receive either 30 ml daily of the oral supplement Carminal plus standard H. pylori therapy or placebo plus standard therapy. Treatment is started after diagnostic upper endoscopy with biopsy and continued for 12 weeks after confirmed H. pylori eradication, with the full study lasting about 24 weeks. The primary outcome is mucosal healing assessed by follow-up endoscopy and histology performed after the treatment period. The trial is interventional, phase 2, and designed to detect whether adding this antioxidant Aloe vera–based supplement improves gastric mucosal recovery beyond standard eradication therapy.
Who should consider this trial
Good fit: Adults aged 18 or older with dyspepsia and histologically confirmed H. pylori–positive gastritis who can provide informed consent are eligible.
Not a fit: Patients with peptic ulcer disease, prior gastric surgery, current or prior malignancy, severe unstable comorbidities, known hypersensitivity to product ingredients, or other exclusionary conditions are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, Carminal could speed mucosal recovery and reduce gastric inflammation after H. pylori eradication, potentially lowering longer-term gastric complications.
How similar studies have performed: Clinical evidence for Aloe vera or similar antioxidant supplements in improving H. pylori–related mucosal healing is limited and mixed, so this approach is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older * Patients with clinical symptoms of dyspepsia * Patients diagnosed with Helicobacter pylori positive gastritis, confirmed by upper endoscopy with histology * Patients who give written informed consent to participate in the study Exclusion Criteria: * Patients with peptic ulcer disease * Patients with previous gastric surgery * Patients with current malignancy or the history of any previous malignancies * Patients taking another investigational product, or have taken any investigational product in the last year * Patients with known hypersensitivity to any ingredients found in the investigational product. * Decompensated intercurrent illnesses, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, and psychiatric illnesses that may limit adherence to the requirements of the clinical trial, or any other special condition that, according to the physician's judgement, jeopardises the patient's health or life during participation in the trial. * Planned pregnancy for the duration of trial, pregnancy, breast feeding, or postpartum period. * Patients with human immunodeficiency virus (HIV).
Where this trial is running
Belgrade, Central Serbia and 1 other locations
- Clinical Center of Serbia - Clinic for Gastroenterohepatology — Belgrade, Central Serbia, Serbia (Recruiting)
- Zvezdara Medical Center - Department of Gastroenterology — Belgrade, Central Serbia, Serbia (Recruiting)
Study contacts
- Principal investigator: Dragana Mijač, MD, PhD — Clinic for Gastroenterohepatology, Clinical Center of Serbia
- Study coordinator: Dragana Mijač, MD, PhD
- Email: draganamijac@gmail.com
- Phone: +381 11 3088672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.