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Trial Title:
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
NCT ID:
NCT05776940
Condition:
Immunoglobulin Light-chain Amyloidosis
Conditions: Official terms:
Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Dexamethasone
Dexamethasone acetate
Bortezomib
Daratumumab
BB 1101
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Description:
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).
Arm group label:
Probiotic group
Other name:
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapy
Intervention type:
Drug
Intervention name:
Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Description:
Naive al amyloidosis patients receive Bortezomib+Dexamethasone,
Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics
(Blank Control).
Arm group label:
Control group
Other name:
Routine therapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 31, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Air Force Military Medical University, China
Agency class:
Other
Source:
Air Force Military Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05776940
