Clinical trial NCT05776940: Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
Official title: Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Immunoglobulin Light-chain Amyloidosis
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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

Primary outcomes:
measure: Occurrence of diarrhea
timeFrame: Up to 3 months after enrollment
Secondary outcomes:
measure: Time before diarrhea
timeFrame: Up to 3 months after enrollment
measure: Duration of the diarrhea
timeFrame: Up to 6 months after enrollment
measure: Hematological response at 3 and 6 months after enrollment
timeFrame: Up to 6 months after enrollment
measure: Involved organ response（heart）at 3 and 6 months after enrollment
timeFrame: Up to 6 months after enrollment
measure: SF-36 score at 1 month, 3 month and 6 month
timeFrame: Up to 6 months after enrollment
measure: GSRS score at 1 month, 3 month and 6 month
timeFrame: Up to 6 months after enrollment
measure: Other adverse events that occurred during the treatment
timeFrame: Up to 6 months after enrollment
measure: Survival status at study endpoints
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment
timeFrame: Up to 6 months after enrollment.
measure: Severity of the diarrhea
timeFrame: Up to 6 months after enrollment
measure: Involved organ response（kidney）at 3 and 6 months after enrollment
timeFrame: Up to 6 months after enrollment
Other outcomes:
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