drugset / Trial / NCT05776940
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
RandomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2023-03-31
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules | Other / unclassified | 250 mg | — |
| Comparator | Bortezomib | Small molecule | — | — |
| Comparator | Daratumumab | Monoclonal antibody | — | — |
| Comparator | Dexamethasone | Small molecule | — | — |