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

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone acetate

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