NCT04639492已完成不适用
Evaluating the Effect and Safety of Postbiotic MBS and Metformin Combination on Gut Microbiota and Symptom in Patients With Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Post-treatment changes of intestinal flora
研究概览
简要总结
The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject who aged from 20 to
- •BMI in between 18.5 and 35 kg/m2 inclusively.
- •Fasting blood sugar ≥ 126 mg/dL, and confirmed diagnosis of type-II diabetes.
- •30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7-10% by medication.
- •Prior to the screening visit (V1), subjects have been regularly taken 500-200 mg/day for at least 90 days.
排除标准
- •Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
- •Subjects who are allergic to soy or products containing it.
- •At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
- •Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
- •Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
- •Subject with impaired renal function confirmed by Serum Total Bilirubin ≥ 1.5 upper limit of normal [ULN], Aspartate Transaminase/ Alanine Transaminase (AST/ALT) ≥ 2 ULN, Creatinine ≥ 2 ULN or eGFR <60 mL/min/1.73 m^
- •Subjects who have been diagnosed with malignant tumors within five (5) years before the screening visit (V1) with exception to subjects with topical cancer but show significant recovery following investigator's assessment, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate or cervix or carcinoma in situ of the breast.
- •30 days prior to screening visit (V1), subjects have taken antibiotics, synthetic drugs (Sulfonamides, Fluoroquinolone, etc.), anti-fungal or anti-viral medication but not limited to topical forms for use in skin application.
- •Within 14 days prior to screening visit (V1), subjects have taken products or supplements that contain probiotics or prebiotics.
- •Within 14 days prior to screening visit (V1), subjects experience diarrhea caused by gastrointestinal infection (3 times of watery stool within 24 hours).
- •Within14 days prior to screening visit (V1), subjects have taken steroids, immunosuppressant, and/or inflammatory medicines.
- •Subjects took or intend to take medications other than metformin that may affect intestinal flora within 30 days prior to screening visit, during screening period or whole trial period. Examples of this kind of medication include DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides, thiazolidinediones, SGLT2 inhibitors, and insulin.
结局指标
主要结局
Post-treatment changes of intestinal flora
时间窗: 4, 8,12 weeks post-treatment
Post-treatment changes from baseline in microbial composition, abundance, variation of subject's intestinal flora at 4, 8, 12 weeks.
次要结局
- Post-treatment changes from baseline in HbA1c at 12 weeks(12 weeks post-treatment)
- Post-treatment changes from baseline in HOMA-IR at 12 weeks(12 weeks post-treatment)
- Post-treatment changes from baseline in immune factors at 12 weeks(12 weeks post-treatment)
- Post-treatment changes from baseline in fasting plasma glucose at 12 weeks(12 weeks post-treatment)
- Post-treatment changes from baseline in blood lipids composition at 12 weeks(12 weeks post-treatment)
- Incidence of treatment-emergent adverse events(TEAE)(12 weeks post-treatment)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy SubjectsHealthy AdultNCT02257151Bristol-Myers Squibb118
终止
1 期
Phase I Ascending Multiple-Dose Study of BMS-986115 in Subjects With Advanced Solid TumorsVarious Advanced CancerNCT01986218Bristol-Myers Squibb36
已完成
1 期
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)Infection, Human Immunodeficiency VirusNCT02063360ViiV Healthcare42
已完成
1 期
A Study of BMS-986205 Given in Combination With Nivolumab in Patients With Advanced TumorsAdvanced CancerNCT03192943Bristol-Myers Squibb11
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy ParticipantsHealth ParticipantsNCT04154800Bristol-Myers Squibb114