Efficacy of Fermented Brown Rice by

Background: Ulcerative colitis (UC) is a diffuse, nonspecific inflammation of the colon of unknown cause. Basic and clinical studies suggest that UC may be ameliorated by dietary fiber intake. Fermented brown rice by Materials and Methods: Patients were divided into two groups: Group A (administered FBRA for 14 weeks, followed by a washout period, and then administered nonfunctional foods (NF) for 14 weeks) and Group B (NF and then FBRA). The primary endpoint is the presence or absence of improvement in clinical activity index (CAI) scores before and after the intervention. The secondary endpoints are the pre- and postintervention changes in blood data indicating inflammation (e.g., high-sensitivity C-reactive protein (CRP)) and nutritional status (e.g., serum proteins), and the adverse events. Results: Fifty-six patients consented to participate: 19 in Group A and 21 in Group B completed the trial. Improvement in the CAI scores was not observed with FBRA. In the ITT analysis of the blood data, however, high-sensitivity CRP, erythrocyte sedimentation rate hourly, white blood cell count, serum protein level, and serum albumin level all tended to be improved from the preintervention level (improvement ratio 1.70; 95% CI 0.97-2.98). No serious adverse event was observed. Conclusion: There is an expectation that FBRA may be effective in improving inflammation in patients with UC. Therefore, a large-scale validation study should be conducted in the future.