Clinical trial
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
Name
Probiotic in AL amyloidosis
Description
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.
Trial arms
Trial start
2023-03-31
Estimated PCD
2026-03-31
Trial end
2026-03-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
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).
Arms:
Probiotic group
Other names:
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapy
Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control).
Arms:
Control group
Other names:
Routine therapy
Size
116
Primary endpoint
Occurrence of diarrhea
Up to 3 months after enrollment
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 116, 'type': 'ESTIMATED'}}
Updated at
2023-03-20
1 organization
2 products
1 indication
Organization
Air Force Military Medical UniversityIndication
Immunoglobulin Light-chain Amyloidosis