Enhanced H. pylori Treatment Using a β-Cyclodextrin-Propolis Complex: A Randomized Clinical Trial.

BACKGROUND

Helicobacter pylori infection poses a significant global health burden, with rising antibiotic resistance and treatment-related side effects highlighting the need for adjunctive therapies. Propolis, a natural resin with known antimicrobial and anti-inflammatory properties, suffers from poor solubility and bioavailability. This study evaluated a β-cyclodextrin-propolis complex designed to enhance delivery and therapeutic efficacy in H. pylori-infected patients.

MATERIALS AND

METHODS

In a double-blind, randomized clinical trial at Hamadan University of Medical Sciences, biopsy-confirmed H. pylori patients received standard quadruple therapy plus omeprazole. The treatment group (n = 28) also received 250 mg/day of the β-cyclodextrin-propolis complex for 2 months; the control group (n = 12) received placebo capsules. Outcomes were assessed using fecal antigen tests and gastrointestinal symptom questionnaires 2 months posttreatment. Characterization of the complex was performed using FESEM, FTIR, and drug release profiling in PBS (pH 7.4).

RESULTS

The complex demonstrated a successful formation and a sustained propolis release profile. Clinically, 57.1% of treated patients achieved negative antigen tests and symptom resolution, compared with 41.6% in the control group. Adverse effects were mild and comparable between groups.

CONCLUSION

These findings suggest that the β-cyclodextrin-propolis complex may serve as an effective natural adjunct to standard H. pylori treatment, offering potential benefits in eradication rates and symptom relief.

TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): 20230503058065N1.