jRCTs031210343已完成不适用
Trial for application of individualized oral prebiotics and probiotics supplements on the subjective severity in patients with irritable bowel syndrome; multicenter, open-label non-randomized, single-arm trial (TAILOR-IBS study)
未提供0 个研究点目标入组 120 人开始时间: 2021年10月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 60age old not（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are included in this study;
- •Patients who are diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D), constipation-predominant irritable bowel syndrome (IBS-C), or mixed-form irritable bowel syndrome (IBS-M) based on Rome IV diagnostic criteria.
- •Male and female aged 20 years or older, and younger than 60 years.
- •Subjects whose native language is Japanese.
- •Subjects who provide their written consent form to participate in the study.
排除标准
- •Patients who meet any of the following criteria are excluded from the study;
- •Patients who took antibiotics or antimicrobial agents within the last 3 months before giving their consent.
- •Patients who are diagnosed with gastrointestinal disorders such as inflammatory bowel disease.
- •Patients with hisotory of major gastrointestinal surgery such as gastrectomy, gastrointestinal suture, or intestinal resection.
- •Patients who have taken antidepressants, antipsychotics, or anxiolytics on a daily basis within the last 3 months before giving their consent (excluding those who take the drugs as needed)
- •Patients who take drugs that suppress immune function at giving their consent.
- •Patients who take drugs that affect blood glucose or blood pressure at giving their consent.
- •Patients with history of allergy against the active ingredients* of the study foods
- •active ingredients: arabinogalactan, Guar Gum degradant, pectin, delipidated rice bran, inulin, cornstarch, psyllium, bifidobacteria, lactobacillus
- •Patients who have a history of cancer in the gastrointestinal organs or who are currently receiving treatment or medications for cancer in the gastrointestinal organs.
- •Patients with serious cerebrovascular disease, cardiac disease, hepatic disease, renal disease, gastrointestinal disease, or infectious disease requiring notification
- •Patients who are pregnant, breastfeeding, possibly pregnant, or planning to be pregnant.
- •Patients who need legal representative for giving their consent.
- •Patients who are considered to be unsuitable for participating in this study by investigators.
结局指标
主要结局
-
Change in total score of IBS-severity scoring system (IBS-SSS) from baseline to week 4
次要结局
- Change in each item score of IBS-SSS(from baseline to week 4)
研究者
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