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

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

Affiliations

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 et al. Infect Drug Resist. .

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.

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Conflict of interest statement

The authors declare that they have no competing interests in this work.

Figures

Figure 1
Figure 1
Protocol flow diagram; We will conduct a 4-week parallel-group, randomized controlled trial to determine the effects of concurrent omega-3 and cranberry juice consumption on eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with Helicobacter pylori infection.

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