Effects of Concurrent Omega-3 and Cranberry Juice Consumption Along with Standard Antibiotic Therapy on the Eradication of Helicobacter pylori, Gastrointestinal Symptoms, Some Serum Inflammatory and Oxidative Stress Markers in Adults with Helicobacter pylori 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:

• controlled clinical trial
• cranberry juice
• fatty acids
• omega-3
• Helicobacter pylori
• inflammation mediators
• oxidative stress
• vaccinium macrocarpon

Acknowledgment

We hereby express our gratitude to the Ahvaz Jundishapur University of Medical Sciences for funding this trial.

Abbreviations

HP, Helicobacter pylori; MALT, mucosa-associated lymphoid tissue; LPS, lipopolysaccharide; Cag A, cytotoxin-associated gene A; Vac A, vacuolating cytotoxin gene A; Bab A, blood group antigen-binding adhesin A; Dup A, duodenal ulcer promoter gene A; T4SS, type IV secretion systems; ALA, α-Linolenic acid; EPA, eicosapentaenoic acid; DHA, docosahexaenoic acid; PG, prostaglandins; IL-1β, interleukin 1β; IL-6, interleukin 6; IL-8, interleukin8; IL-12, interleukin 12; TNF-alpha, tumor necrosis factor-alpha; NF-κB, nuclear factor kappa-light-chain-enhancer of activated B cells; COX-2, cyclooxygenase-2; iNOS, inducible nitric oxide synthase; IL-17, interleukin 17; TGFβ1, transforming growth factor beta-1; INF-γ, interferon gamma; MDA, malondialdehyde; TAC, total antioxidant capacity; IPAQ, International Physical Activity Questionnaire.

Ethics Approval and Consent to Participate

This protocol, approved by the Medical Ethics Committee of Ahvaz University of Medical Sciences, is in accordance with the Declaration of Helsinki (approval number: IR.AJUMS.REC.1396.819). Each participant will sign an informed consent form. This randomized clinical trial was registered on the Iranian Registry of Clinical Trials (IRCT registration number: IRCT20151128025274N3).

Author Contributions

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Disclosure

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