Efficacy of Fermented Brown Rice by Aspergillus oryzae (FBRA) in Ulcerative Colitis: A Double-Blind Randomized Trial

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 Aspergillus oryzae (FBRA) is produced by fermenting brown rice and bran with A. oryzae. We aimed to evaluate the efficacy of FBRA in patients with UC by a double-blind, randomized crossover trial.

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.

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.

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.