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
Received 30 June 2020
Accepted for publication 3 September 2020
Published 15 September 2020 Volume 2020:13 Pages 3179—3185
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Suresh Antony
Ahmad Zare Javid,1,2 Leila Maghsoumi-Norouzabad,1,2 Hadi Bazyar,1,3 Vahideh Aghamohammadi,4 Pejman Alavinejad5
1Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; 2Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; 3Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; 4Department of Nutrition, Khalkhal University of Medical Sciences, Khalkhal, Iran; 5Alimentary Tract Research Center, Imam Khomeini Hospital Clinical Research Development Unit, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Correspondence: Vahideh Aghamohammadi
Department of Nutrition, Khalkhal University of Medical Sciences, Khalkhal, Iran
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
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