CTRI/2024/03/064023招募中3 期
A randomized, double blind, placebo controlled, parallel, mulitcenter, phase 3 study on genetic and clinical evaluation of probiotic Akkermansia Muciniphila strain in patients with irritable bowel syndrome. - NI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
入选标准
- •1.Patient should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least a day or week in the last 3 month associated with two or more of the following:(Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)].
- •2.Patients willing to provide written informed consent and comply to protocol requirements.
排除标准
- •1.Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding.
- •2.Known inflammatory bowel disease or celiac disease patients.
- •3.Immuno-compromised patients
- •4.Pregnancy or wishing to become pregnant during the study.
- •5.End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases greater than 3.5x above normal)
- •6.The use of other probiotic products or antibiotics over the previous 6 months
- •7.Participation in other clinical trials
- •8.The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)
研究者
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