Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 116
- Primary Endpoint
- Occurrence of diarrhea
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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).
Intervention: 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.
Intervention: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab (Drug)
Outcomes
Primary Outcomes
Occurrence of diarrhea
Time Frame: Up to 3 months after enrollment
Increased stool frequency and/or loose or watery stools
Secondary Outcomes
- 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)
Investigators
Shiren sun
Professor
Air Force Military Medical University, China