JPRN-UMIN000048456已完成Unknown
Effects of consumption of the food containing lactic acid bacteria on the intestinal environment in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the food containing lactic acid bacteria on the intestinal environment in healthy Japanese subjects
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 64years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Subjects (who/whose) 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an implantable cardioverter defibrillator (ICD) 3.currently undergoing treatment for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension 4.have chronic constipation 5.have other diseases that may significantly affect bowel movement, or who have a medical history of them 6.have asthma, or may develop asthma during this trial 7.occupancy rate of Lactobacillales order or Bifidobacterium at screening (before consumprion; Scr) is 0% 8.usually use foods containing rich in lactic acid bacteria, or lactic acid bacteria fortified health foods or medicines 9.usually use foods containing rich in Bacillus subtilis var. natto (B. natto), or B. natto fortified health foods or medicines 10.usually use medicines, health foods, "Foods for Specified Health Uses (FOSHU)," or "Foods with Functional Claims (FFC)" that may affect bowel movement / take ingredients affecting bowel movement (such as dietary fiber) fortified foods 11.usually use or take other FOSHU or FFC 12.currently taking medications (including herbal medicines) and supplements 13.are allergic to medicines and/or the test food related products 14.are day- and night- shift workers / work night multiple times during this trial 15.plan to go abroad during this trial 16.anthropometric measurements, physical examination values or laboratory values markedly deviate from the reference values at pre-consumption test 17.are pregnant, lactation, or planning to become pregnant during this trial 18.suffer from COVID-19 19.have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 20.are judged as ineligible to participate in this study by the physician
研究者
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