Clinical trial · Interventional
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
NCT05776940CI-TRIAL-00064822unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunoglobulin Light-chain Amyloidosis | AL Amyloidosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab | Drug | — | UNRESOLVED |
| Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Probiotic group
- 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).
- interventionNames
- Drug: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics.
- interventionNames
- Drug: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.