Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
- Conditions
- Immunoglobulin Light-chain Amyloidosis
- Sponsor
- Air Force Military Medical University, China
- Enrollment
- 116
- Primary Endpoint
- Occurrence of diarrhea
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
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.
Investigators
Shiren sun
Professor
Air Force Military Medical University, China
Eligibility Criteria
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
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
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)