NCT05776940View on ClinicalTrials.gov

Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Immunoglobulin Light-chain Amyloidosis
Interventions
DRUG

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).

DRUG

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).

All Listed Sponsors
lead

Air Force Military Medical University, China

OTHER

NCT05776940 - Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis | Biotech Hunter | Biotech Hunter