Abstract
BACKGROUND: One of the unfortunate events after bariatric surgery is the weight regain, which occurs in some patients. Food addiction is an eating disorder related to the brain-intestinal axis and can be effective in weight regain after bariatric surgery. In addition, the gut microbiome plays a vital role in eating behaviors, including food addiction. So, this study will aim to evaluate the effects of probiotic supplementation with a weight-reducing diet and cognitive behavioral therapy on anthropometric measures, body composition, eating behavior, and related hormone levels, leptin, oxytocin, and serotonin, in patients with food addiction and weight regain after bariatric surgery. METHODS: We will carry out a triple-blinded randomized clinical trial for 12 weeks to evaluate the effect of probiotic supplementation with a weight-reducing diet and cognitive behavioral therapy on anthropometric measures, body composition, eating behavior, and related hormone levels including leptin, oxytocin, and serotonin, in patients with food addiction and weight regain after bariatric surgery. DISCUSSION: Based on the available evidence, probiotic supplementation by modifying the intestinal microbiome can improve food addiction and subsequent weight loss. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20220406054437N1 Registered on 2022-06-01.