Eighty patients will be included and randomized in two groups, one group (40 patients) will be administered 30 ml of the supplement Carminal, once a day, plus therapy for HP gastitis and the control group (40 patients) will be given standard therapy for HP gastritis with placebo. Treatment will begin after complection of upper endoscopy with histology results from biopted gastric mucosa. Treatment with Carminal will be continued after successful HP eradication during 12 weeks. The final evaluation will take place 12 weeks after the last Carminal intake, when control endoscopy with histology will be performed. The study will last approximately 24 weeks.
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
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
Parallel
Carminal Oral solution
Dietary supplementCarminal is an oral dietary supplement presented in 30 ml vials, administered once daily (1 vial BID). It contains Aloe vera extract, olive extract, glutamic acid, zinc, and other components with potential antioxidant, anti-inflammatory, and immunomodulatory effects on gastric mucosa. In this study, Carminal is administered for 14 days during standard Helicobacter pylori eradication therapy, followed by 12 weeks of continued treatment post-eradication to support mucosal recovery and improve dyspeptic symptoms.
Placebo
Other interventionPlacebo is an oral solution presented in 30 ml vials, identical in appearance, taste, color, and smell to Carminal, but without any active ingredients. It is administered once daily (1 vial BID) for 14 days during standard Helicobacter pylori eradication therapy, followed by 12 weeks of continued placebo treatment post-eradication. This comparator is used to evaluate the efficacy of Carminal in mucosal recovery and symptom improvement in patients with H. pylori positive gastritis.
Glasgow Dyspepsia Severity Score
Change in dyspeptic symptoms assessed using the Glasgow Dyspepsia Severity Score questionnaire at baseline, after eradication therapy, and at the end of Carminal/placebo treatment.
Endoscopic assessment of gastric mucosa
Endoscopic evaluation of gastric mucosa performed before treatment and at the end of the study to assess mucosal recovery, including presence of gastritis, intestinal metaplasia, and other morphological changes.
Histological assessment of gastric mucosa
Histological analysis of gastric biopsies to evaluate inflammation, atrophy, foveolar hyperplasia, and intestinal metaplasia before and after treatment.
Leeds Dyspepsia Score
Change in dyspeptic symptoms assessed using the Leeds Dyspepsia Score questionnaire at baseline, after eradication therapy, and at the end of treatment.
Helicobacter pylori status (HP antigen stool test)
HP antigen presence in stool samples to confirm eradication success after 14-day standard therapy.
Patient satisfaction after treatment completion
Patient-reported satisfaction with treatment outcomes collected via questionnaire at the end of the study.
Occurrence of adverse events
Monitoring and recording of any adverse events (AEs), including type, duration, intensity, seriousness, and outcome.
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