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
- PMID: 32982332
- PMCID: PMC7508030
- 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
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.
© 2020 Zare Javid et al.
Conflict of interest statement
The authors declare that they have no competing interests in this work.
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References
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- Hunt R, Xiao S, Megraud F, et al. Helicobacter pylori in developing countries. World Gastroenterol Organ Global Guidelines. 2010;1–5.
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