Effects of soy milk consumption on gut microbiota, inflammatory markers, and disease severity in patients with ulcerative colitis: a study protocol for a randomized clinical trial

This study is a randomized clinical trial, in which thirty patients with mild to moderate severity of UC will be randomly allocated to receive either 250  mL/day soy milk plus routine treatments (n = 15) or only routine treatments (n = 15) for 4 weeks. Assessment of anthropometric measures and biochemical indicators including serum concentrations of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interferon gamma (IFN-γ) will be done at the study baseline and end of trial. In addition, the quantity of butyrate-producing bacteria includingClostridium cluster IV,Faecalibacterium prausnitzii, andRoseburia spp.; prebiotic bacteria includingLactobacillus spp. andBifidobacteria spp.; and mucus-degrading bacteria includingAkkermansia muciniphila,Bacteroides fragilis, andRuminococcus spp., as well as calprotectin and lactoferrin levels, will be explored in fecal samples. Also, theFirmicutes toBacteroidetes ratio which is of significant relevance in human gut microbiota composition will be assessed.DiscussionAltered gut microbiota has been reported as an important contributing factor to inflammation in patients with inflammatory bowel disease (IBD). Soy milk contains several components such as phytoestrogens with potential anti-inflammatory properties. This product might affect gut microbiota through its protein and fiber content. Therefore, soy milk might beneficially affect systemic inflammation, gut microbi...
Source: Trials - Category: Research Source Type: clinical trials