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 p...

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Publicado en:BioMed Research International Vol. 2026; pp. 1 - 12
Autores principales: Mehri, Aisa, Pourmoslemi, Shabnam, Khalilian, Alireza, Safari, Mahdi, Ayubi, Erfan, Himangshu, Himangshu
Formato: pictorial research tables/charts randomized controlled trial Journal Article
Publicado: Wiley-Blackwell 7/7/2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 7/7/2026
      vid: 2026
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        195154775
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        10.1155/bmri/6257147
        195154775
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        atl: Enhanced H. pylori Treatment Using a β‐Cyclodextrin–Propolis Complex: A Randomized Clinical Trial.
      aug:
        au:
          Mehri, Aisa
          Pourmoslemi, Shabnam
          Khalilian, Alireza
          Safari, Mahdi
          Ayubi, Erfan
          Himangshu, Himangshu
        affil: Department of Pharmaceutics,, School of Pharmacy,, Hamadan University of Medical Sciences,, Hamadan, Iran, umsha.ac.ir
      sug:
        subj:
          Helicobacter Infections Drug Therapy
          Glucans Therapeutic Use
          Glucans Pharmacodynamics
          Propolis Therapeutic Use
          Propolis Pharmacodynamics
          Drug Efficacy Evaluation
          Drug Delivery Systems
          Human
          Iran
          Female
          Male
          Randomized Controlled Trials
          Random Assignment
          Control Group
          Double-Blind Studies
          Sample Size Determination
          Microscopy, Electron, Scanning
          Glucans Administration and Dosage
          Propolis Administration and Dosage
          Placebos
          Particle Size
          Spectrophotometry, Infrared
          Adult
          Middle Age
          Aged
          Bismuth Administration and Dosage
          Amoxicillin Administration and Dosage
          Metronidazole Administration and Dosage
          Omeprazole Administration and Dosage
          Treatment Duration
          Treatment Outcomes
          Comparative Studies
          Drug Resistance, Microbial
          T-Tests
          Chi Square Test
          Fisher's Exact Test
          Mann-Whitney U Test
          Data Analysis Software
          Descriptive Statistics
          Funding Source
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Aged: 65+ years
          Female
          Male
      ab: 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.
      pubtype: Academic Journal
      doctype:
        pictorial
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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