Effects of Concurrent Omega-3 and Cranberry Juice Consumption Along with Standard Antibiotic Therapy on the Eradication of Helicobacter p ylori, Gastrointestinal Symptoms, Some Serum Inflammatory and Oxidative Stress Markers in Adults with Helicobacter p ylori Infection: A Study Protocol for a Randomized Controlled Trial

Ahmad Zare Javid; Leila Maghsoumi-Norouzabad; Hadi Bazyar; Vahideh Aghamohammadi; Pejman Alavinejad

doi:10.2147/IDR.S270057

Effects of Concurrent Omega-3 and Cranberry Juice Consumption Along with Standard Antibiotic Therapy on the Eradication of Helicobacter p ylori, Gastrointestinal Symptoms, Some Serum Inflammatory and Oxidative Stress Markers in Adults with Helicobacter p ylori Infection: A Study Protocol for a Randomized Controlled Trial

Infect Drug Resist. 2020 Sep 15:13:3179-3185. doi: 10.2147/IDR.S270057. eCollection 2020.

Authors

Ahmad Zare Javid^{1

2}, Leila Maghsoumi-Norouzabad^{1

2}, Hadi Bazyar^{1

3}, Vahideh Aghamohammadi⁴, Pejman Alavinejad⁵

Affiliations

¹ Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
² Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
³ Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
⁴ Department of Nutrition, Khalkhal University of Medical Sciences, Khalkhal, Iran.
⁵ Alimentary Tract Research Center, Imam Khomeini Hospital Clinical Research Development Unit, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Abstract

Background: It seems alternative treatments such as antioxidant intervention and anti-inflammatory intervention adjuvant to antibiotic regimens may enhance cancer prevention approaches and decrease adverse side effects related to therapeutic antibiotic regimens. So, we will evaluate the effects of concurrent omega-3 and cranberry juice supplementation along with standard antibiotic therapy on the eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with HP infection.

Methods: We will conduct a 4-week double-blinded randomized clinical trial. The subjects will be randomly stratified according to sex and BMI using a permuted block randomization procedure by Random Allocation Software (RAS). They will be assigned to one of the four study groups: (1) cranberry juice fortified with omega-3 Intervention (n=23), (2) cranberry juice intervention group (n=23), (3) placebo beverage fortified with omega-3 intervention group (n=23), and (4) placebo beverage intervention (control group) (n=23). All statistical analyses will be performed using IBM SPSS Statistics software.

Discussion: A combination of alternative therapies may have a synergistic effect compared to a single approach. It could potentially be more effective in promoting the efficacy of standard antibiotic therapy in eradicating HP infection.

Trial registration: Iranian Registry of Clinical Trials (IRCT20151128025274N3, www.irct.ir/trial/28997).

Trial status: This study is in the early stages of sampling.

Keywords: Helicobacter pylori; controlled clinical trial; cranberry juice; fatty acids; inflammation mediators; omega-3; oxidative stress; vaccinium macrocarpon.

Grants and funding

This study is financially supported by the Nutrition and Metabolic Disease Research Center of Ahvaz Jundishapur University of Medical Sciences (Grant number: NRC-9623). The funding role included providing the materials for the research and supporting the researchers. However, the funder had no role in data analysis, decision to publish, or preparation of the manuscript.