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

Primary Purpose

Immunoglobulin Light-chain Amyloidosis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Immunoglobulin Light-chain Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Probiotic group

    Control group

    Arm 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).

    Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics.

    Outcomes

    Primary Outcome Measures

    Occurrence of diarrhea
    Increased stool frequency and/or loose or watery stools

    Secondary Outcome Measures

    Time before diarrhea
    Time interval from the start of treatment to the first diarrhea
    Duration of the diarrhea
    The time between the start of diarrhea and the last diarrhea.
    Hematological response at 3 and 6 months after enrollment
    Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis.
    Involved organ response（heart）at 3 and 6 months after enrollment
    Involved organ response（heart）is evaluated according to the change of NT-proBNP.
    SF-36 score at 1 month, 3 month and 6 month
    The general health condition is evaluated by the 36-item Short-Form. The SF-36 measure consists of 36 items that address the following 8 dimensions: physical pain, mental health, general health, emotional role functioning, social functioning, vitality, and physical and role functioning. Each dimension receives a final score between 0 and 100, with 100 representing the best performance.
    GSRS score at 1 month, 3 month and 6 month
    The Gastrointestinal Symptoms are evaluated by Gastrointestinal Symptom Rating Scale. The minimum and maximum values is 15 and 105, respectively. The scores are calculated by taking the mean of the items completed within an individual scale, with higher scores indicating greater severity of symptoms.
    Other adverse events that occurred during the treatment
    Adverse events are evaluated according to the CTCAE 5.0.
    Survival status at study endpoints
    Survival status（live or dead）
    Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment
    The changes of gut microbiome are evaluated by 16sRNA (such as Microbiota α-diversity and β-diversity、Changes in gut microbiota at the phylum and the genus levels、Phylogenetic profiles of the gut microbial communities、Microbial functional alteration、Correlations between significantly different ASVs and clinical characteristics in AL amyloidosis patients.etc.)
    Severity of the diarrhea
    The severity of diarrhea was graded according to the CTCAE 5.0.
    Involved organ response（kidney）at 3 and 6 months after enrollment
    Involved organ response（kidney）is evaluated according to the change of 24h proteinuria.

    Full Information

    First Posted
    February 8, 2023
    Last Updated
    March 18, 2023
    Sponsor
    Air Force Military Medical University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05776940
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2026 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Air Force Military Medical University, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immunoglobulin Light-chain Amyloidosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic group
    Arm Type
    Active Comparator
    Arm 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).
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics.
    Intervention Type
    Drug
    Intervention Name(s)
    Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
    Other Intervention Name(s)
    Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapy
    Intervention 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).
    Intervention Type
    Drug
    Intervention Name(s)
    Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
    Other Intervention Name(s)
    Routine therapy
    Intervention Description
    Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control).
    Primary Outcome Measure Information:
    Title
    Occurrence of diarrhea
    Description
    Increased stool frequency and/or loose or watery stools
    Time Frame
    Up to 3 months after enrollment
    Secondary Outcome Measure Information:
    Title
    Time before diarrhea
    Description
    Time interval from the start of treatment to the first diarrhea
    Time Frame
    Up to 3 months after enrollment
    Title
    Duration of the diarrhea
    Description
    The time between the start of diarrhea and the last diarrhea.
    Time Frame
    Up to 6 months after enrollment
    Title
    Hematological response at 3 and 6 months after enrollment
    Description
    Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis.
    Time Frame
    Up to 6 months after enrollment
    Title
    Involved organ response（heart）at 3 and 6 months after enrollment
    Description
    Involved organ response（heart）is evaluated according to the change of NT-proBNP.
    Time Frame
    Up to 6 months after enrollment
    Title
    SF-36 score at 1 month, 3 month and 6 month
    Description
    The general health condition is evaluated by the 36-item Short-Form. The SF-36 measure consists of 36 items that address the following 8 dimensions: physical pain, mental health, general health, emotional role functioning, social functioning, vitality, and physical and role functioning. Each dimension receives a final score between 0 and 100, with 100 representing the best performance.
    Time Frame
    Up to 6 months after enrollment
    Title
    GSRS score at 1 month, 3 month and 6 month
    Description
    The Gastrointestinal Symptoms are evaluated by Gastrointestinal Symptom Rating Scale. The minimum and maximum values is 15 and 105, respectively. The scores are calculated by taking the mean of the items completed within an individual scale, with higher scores indicating greater severity of symptoms.
    Time Frame
    Up to 6 months after enrollment
    Title
    Other adverse events that occurred during the treatment
    Description
    Adverse events are evaluated according to the CTCAE 5.0.
    Time Frame
    Up to 6 months after enrollment
    Title
    Survival status at study endpoints
    Description
    Survival status（live or dead）
    Time Frame
    From date of randomization until the date of death from any cause, assessed up to 36 months
    Title
    Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment
    Description
    The changes of gut microbiome are evaluated by 16sRNA (such as Microbiota α-diversity and β-diversity、Changes in gut microbiota at the phylum and the genus levels、Phylogenetic profiles of the gut microbial communities、Microbial functional alteration、Correlations between significantly different ASVs and clinical characteristics in AL amyloidosis patients.etc.)
    Time Frame
    Up to 6 months after enrollment.
    Title
    Severity of the diarrhea
    Description
    The severity of diarrhea was graded according to the CTCAE 5.0.
    Time Frame
    Up to 6 months after enrollment
    Title
    Involved organ response（kidney）at 3 and 6 months after enrollment
    Description
    Involved organ response（kidney）is evaluated according to the change of 24h proteinuria.
    Time Frame
    Up to 6 months after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shiren Sun, Doctor
    Phone
    18520955728
    Email
    1019282726@qq.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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