JPRN-jRCTs051220127进行中（未招募）Unknown
Efficacy of Bifidobacteria intake on gastrointestinal symptoms in Symptomatic Type 2 diabetes mellitus patients in Abdominis; open-label, Randomized-controlled trial - Binary STAR study
Fukui Michiaki0 个研究点目标入组 100 人开始时间: 2022年12月6日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are included in this study:
- •1. Patients with gastrointestinal symptoms such as diarrhea or constipation
- •2. Patients whose mean Gastrointestinal Symptom Rating Scale (GSRS) subdomain score (diarrhea, constipation) is three or higher
- •3. Patients who are diagnosed with type 2 diabetes mellitus without neuropathy
- •4. Patients who do not use new antibiotics within 12 weeks before giving their consent
- •5. Patients who are not treated with new interventions for diet therapy within 12 weeks before giving their consent
- •6. Patients who do not change concomitant drugs (addition or withdrawal of the concomitant drugs or change of usage or dose of the concomitant drugs)* that may affect gastrointestinal symptoms or gut microbiota within 12 weeks before giving their consent
- •*including patients who are using GLP-1 receptor agonists. Patients who need dose titration of the GLP-1 receptor agonists cannot be included in this study. While, patients who are using insulin and need dose titration of the insulin can be included in this study.
- •7. Male and female aged 20 years or older, and 75 years or younger when giving their consent
- •8. Patients who give their consent in a written form
排除标准
- •Patients who fall into any of the following criteria are excluded from participating in the study:
- •1. Patients whose mean weekly defecation is less than once, or 42 times or more within 4 weeks before giving their consent
- •2. Patients who are diagnosed to have structural diseases* by colonoscopy within 5 years before giving their consent
- •*Patients with polyps or diverticula that are not considered to affect gastrointestinal function can be included in this study. While, patients with inflammatory diseases (infectious enteritis, diverticulitis, Crohn's disease, ulcerative colitis, etc.) or stenotic lesions, that are likely to affect gastrointestinal function cannot be inclued in this study.
- •3. Patients with GSRS constipation subdomain score of 3 points or higher, and with Bristol stool form scale of higher than 4 points
- •4. Patients with GSRS diarrhea subdomain score of 3 points or higher, and with Bristol stool form scale of less than 4 points
- •5. Patients with both gastrointestinal symptoms of diarrhea and constipation (e.g. patients with mixed-type irritable bowel syndrome)
- •6. Patients with history or complication of celiac disease or inflammatory bowel disease
- •7. Patients with HbA1c of 9% or higher at giving their consent
- •8. Patients who used alpha-glucosidase inhibitor within 4 weeks before giving their consent
- •9. Patients who are suffered by myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
- •10. Patients with severe hepatic dysfunction (AST or ALT is 5 times or more higher than upper limit in the collaborative research institutions
- •11. Patients with severe renal dysfunction (eGFR is less than 30 ml/min/1.73 square meter)
- •12. Patients with malignant neoplasm
- •13. Patients with history of allergy against bifidobacteria
- •14. Patients who use any other drugs or supplements which affect the functions of the inestines
- •15. Patients who use drugs which have high possibility to cause gastrointestinal symptoms (prokinetic agents*, gastrointestinal dysfunction the rapeutic agents, antiemetic agents, or anticholinergic agents, etc.)
- •*Patients who are using PPI or H2blockers can be included in this study, however, initiation or dose change after giving their consent is prohibited.
- •16. Patients who change their dietary habit within 12 weeks before giving their consent
- •17. Patients with other conditions that the investigator or researcher thinks inappropriate for the study
研究者
相似试验
已完成
不适用
Effects of Bifidobacterium on immune and gastrointestinal function - A Randomized, Double-blind, Placebo-controlled, Parallel-group StudyJPRN-UMIN000042392DeNA Life Science, Inc100
已完成
不适用
Effect of Bifidobacterium on intestinal microinflammation and irritable bowel syndrome-like symptomsCrohn's diseaseJPRN-jRCTs031200327Fukui Hirokazu12
已完成
不适用
Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trialJPRN-UMIN000033295Graduate School of Medicine, Chiba University100
已完成
不适用
Efficacy of probiotic food containing bifidobacterium for chronic constipation in maintenace hemodialysis patients.Chronic kidney diseaseJPRN-UMIN000012889Tokai Central Hospiotal of Japan Mutual Aid Association of Public School Teachers25
已完成
不适用
A Study for the effect of Bifidobacterium-containing food intake on cognitive function for healthy elderly subjectJPRN-UMIN000033917TTC Co., Ltd60