JPRN-jRCTs031220479招募中Unknown
Efficacy of probiotics (Biofermin) in patients with Renal dysfunction (Diabetic kidney disease) complicated with constipation; an Exploratory, multicenter, open-label, single-arm before-after study - BIRDIE study
Hirotaka Watada0 个研究点目标入组 30 人开始时间: 2022年11月29日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. patients with type 2 diabetes mellitus
- •2. patients with HbA1c of 6.5% or higher, and less than 9.0% at giving their consent
- •3. patients with constipation symptoms
- •4. patients with stage 2 to 4 diabetic nephropathy
- •5. patients aged 18 years or older, and 75 years or younger at giving their consent
- •6. patients who give their consent in a written form
- •1. patients with fecal condition (mean of Bristol Scale within 2 weeks before visit 1 (baseline (week 0))) of less than 3.5
- •2. patients who privide their fecal samples at visit 1 (baseline (week 0))
排除标准
- •1. patients who had myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
- •2. patients with severe hepatic dysfunction (AST or ALT > 5 times the upper limit of the reference value of the participating medical institution)
- •3. patients with stage 5 diabetic nephropathy or on dialysis
- •4. patients with malignant neoplasms*
- •*Patients who have a history of malignant neoplasms but who have been already cured can be enrolled. However, patients with a hisotory of or with current malignant neoplasms in stomach, small intestine, or large intestine are exclued.
- •5. patients with history of allergy to bifidobacteria
- •6. patients who have been consuming foods or supplements such as yogurt or chocolate containing bifidobacteria on a daily basis within 4 weeks before giving their consent. Daily intake is defined as intake at least once a day.
- •7. patients who have received new antibiotics within 12 weeks before giving their consent
- •8. patients who have received intestinal regulator (except constipation reliever) within 12 weeks before giving their consent
- •9. patients who have received a new dietary intervention within 12 weeks before giving their consent
- •10. patients who have changed (added, discontinued, or changed the dose of) medications that may influence bowel or gastrointestinal function, or antidiabetic agents* that may influence glyemic control within 12 weeks before giving their consent
- •*Patients who titratted insulin injection can be enrolled. However, patients who titrated combination injection of insulin and GLP-1 receptor agnosist are excluded.
- •11. patients with other conditions that the investigators judge to be inappropriate for the study
- •1. patients who took foods or supplements such as yogurt or chocolate containing bifidobacteria on a daily basis for 4 weeks after giving their consent until the actual enrollment. Daily intake is defined as intake at least once a day.
- •2. patients who received antibiotics after giving their consent until the actual enrollment
- •3. patients who received dietary intervention after giving their consent until the actual enrollment
- •4. patients who have changed (added, discontinued, or changed the dose of) any medication after giving their consent until the actual enrollment
- •5. patients who have received intestinal regulator (except constipation reliever) after giving their consent until the actual enrollment
- •6. patients who had myocardial infarction, cerebral infarction, or stroke after giving their consent until the actual enrollment
- •7. patients with other conditions that the investigators judge to be inappropriate for the study
研究者
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