The placebo is designed to match the flavor, color, and taste of prune juice (see Table 1, Supplementary Digital Content, ). Subjects were randomly assigned to the prune juice group or placebo group and consumed 54 g of each test food in a day for 8 weeks. The criterion for chronic constipation was defined according to Rome IV as fewer than 3 bowel movements per week and/or hard stool defined by the Bristol Stool Form Scale (BSFS) 1 or 2, for the past 3 months, with symptom onset at least 6 months earlier ( 6). This study included subjects aged 20–75 years who presented symptoms of treatment-naive chronic constipation. Written informed consent was obtained from all subjects before their enrollment into this study. This study was conducted in accordance with the Declaration of Helsinki with the approval of the institutional review boards of the Miura Clinic (approval number: R2001) and Tokyo Medical University (approval number: T2021-0243). We aimed to evaluate the effects of prune juice consumption on stool consistency and subjective complaints of constipation symptoms in Japanese subjects with chronic constipation. Among natural foods, prune potentially exerts an ameliorating effect on constipation ( 4,5), but little data are available on the effectiveness in chronic constipation subjects or on side effects such as abdominal discomfort or diarrhea symptoms. Instead of drug treatment, there has been increasing recognition of natural food treatment, which is beneficial in its safety and prevalence ( 3). There are a wide variety of laxatives available for chronic constipation treatment, but they have several problems, including side effects and insufficient efficacy ( 1,2).
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