Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- Occurrence of diarrhea
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether specific probiotic can reduce gastrointestinal symptoms and improves therapeutic response, on a background of Bortezomib+dexamethasone or Bortezomib+dexamethasone combined with daratumumab therapy, for naive AL amyloidosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Biopsy-proven naive AL amyloidosis
- •Receive at least 1 course of treatment based on Bortezomib+Dexamethasone or Bortezomib+Dexamethasone+Daratumumab therapy
- •At least 1 organ (heart, kidney, liver, etc) involved
- •Agree to participate in the project and sign the informed consent.
排除标准
- •Received antibiotics for 3 consecutive days and on in the past 2 months prior to the enrollment
- •Had history of probiotics, prebiotics, immunosuppressants, hormones, and other medications use in the past 3 months that influence the Gastrointestinal Microbiome
- •Had other underlying diseases（malignancy or immune system diseases, etc.）
- •Had history of clearly diagnosed chronic gastrointestinal disease
- •Secondary AL amyloidosis or local AL amyloidosis
- •Other conditions the researcher judged unsuitable for enrollment
研究组 & 干预措施
Probiotic group
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy combined with Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules( 250mg/time, bid,up to 3 months).
干预措施: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab (Drug)
Control group
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics.
干预措施: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab (Drug)
结局指标
主要结局
Occurrence of diarrhea
时间窗: Up to 3 months after enrollment
Increased stool frequency and/or loose or watery stools
次要结局
- Severity of the diarrhea(Up to 6 months after enrollment)
- Time before diarrhea(Up to 3 months after enrollment)
- Duration of the diarrhea(Up to 6 months after enrollment)
- Hematological response at 3 and 6 months after enrollment(Up to 6 months after enrollment)
- Involved organ response（heart）at 3 and 6 months after enrollment(Up to 6 months after enrollment)
- SF-36 score at 1 month, 3 month and 6 month(Up to 6 months after enrollment)
- GSRS score at 1 month, 3 month and 6 month(Up to 6 months after enrollment)
- Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment(Up to 6 months after enrollment.)
- Other adverse events that occurred during the treatment(Up to 6 months after enrollment)
- Involved organ response（kidney）at 3 and 6 months after enrollment(Up to 6 months after enrollment)
- Survival status at study endpoints(From date of randomization until the date of death from any cause, assessed up to 36 months)
研究者
Shiren sun
Professor
Air Force Military Medical University, China