ACTRN12621001441808已完成未知
The Clinical Evaluation of deactivated Bacillus subtilis BG01-4™ in subjects with Functional Gastrointestinal Disorder (FGID) in relieving symptoms including bloating/gas, diarrhoea and constipations.
Dr Craig Patch0 个研究点目标入组 67 人开始时间: 2021年10月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 67
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Participants are self-reported functional gastrointestinal disorder in the last 3 months, and have one or more of the following self-reported symptoms experienced for the at least 6 months or longer (meeting the ROME IV criteria for functional gastrointestinal disorder):
- •a) Recurrent stomach bloating and/or distension occurring on average at least 1 day/week; andabdominal bloating and/or distension predominates over other symptoms, such as minorbowel movement abnormalities.
- •b) Loose or watery stools, without predominant abdominal pain or bothersome bloating,occurring in more than 25% of stools. (However if you have been diagnosed with IBS-D(diarrhea-predominant IBS) will not be eligible for this study).
- •c) Functional constipation: straining during more than 25% of defecation per week; sensation ofanorectal obstruction/blockage or incomplete evacuation more than 25% of defecations;needing manual maneuvers (e.g., digital assistance) to help with more than 25% of defecations;loose stools are rare without the use of laxatives.
排除标准
- •a) Participants who had a clinical diagnosis of irritable bowel disease (IBD)
- •b) Participants who have opioid-induced constipation (OIC).
- •c) Participants who are intolerant to maltodextrin (food ingredient).
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