Immunoglobulin Light-chain AmyloidosisPhase 3NCT05776940
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
A Phase 3 study testing Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab and Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab in people with Immunoglobulin Light-chain Amyloidosis, run by Air Force Military Medical University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin Light-chain Amyloidosis
- What is being tested?
- Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab and Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2023to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
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
- Immunoglobulin Light-chain Amyloidosis
- Being tested
- 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
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabDrug
Also called Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapy
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).
Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabDrug
Also called Routine therapy
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | 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). Receives: Drug: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab |
| Control group | Active comparator | Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics. Receives: Drug: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of diarrhea
Increased stool frequency and/or loose or watery stools
Measured: Up to 3 months after enrollment
Secondary outcomes (11)
Time before diarrhea
Time interval from the start of treatment to the first diarrhea
Measured: Up to 3 months after enrollment
Duration of the diarrhea
The time between the start of diarrhea and the last diarrhea.
Measured: Up to 6 months after enrollment
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.
Measured: Up to 6 months after enrollment
Involved organ response（heart）at 3 and 6 months after enrollment
Involved organ response（heart）is evaluated according to the change of NT-proBNP.
Measured: Up to 6 months after enrollment
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.
Measured: Up to 6 months after enrollment
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.
Measured: Up to 6 months after enrollment
Other adverse events that occurred during the treatment
Adverse events are evaluated according to the CTCAE 5.0.
Measured: Up to 6 months after enrollment
Survival status at study endpoints
Survival status（live or dead）
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
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.)
Measured: Up to 6 months after enrollment.
Severity of the diarrhea
The severity of diarrhea was graded according to the CTCAE 5.0.
Measured: Up to 6 months after enrollment
Involved organ response（kidney）at 3 and 6 months after enrollment
Involved organ response（kidney）is evaluated according to the change of 24h proteinuria.
Measured: Up to 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start31 Mar 2023 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin Light-chain AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776940
- Sponsor's protocol ID
- Probiotic in AL amyloidosis
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05776940
- Acronym / sponsor ID
- Probiotic in AL amyloidosis
- Conditions
- Immunoglobulin Light-chain Amyloidosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 31 Mar 2023 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Drug: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabNaive 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). |
| Control group | Active comparator | Drug: Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabNaive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabAlso: Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapyNaive 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 | Probiotic group |
| Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single DaratumumabAlso: Routine therapyNaive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics (Blank Control). | Drug | Control group |
Primary outcome
Occurrence of diarrhea
Time frame: Up to 3 months after enrollment
Increased stool frequency and/or loose or watery stools
11 secondary outcomes
Time before diarrhea
Time frame: Up to 3 months after enrollment
Duration of the diarrhea
Time frame: Up to 6 months after enrollment
Hematological response at 3 and 6 months after enrollment
Time frame: Up to 6 months after enrollment
Involved organ response（heart）at 3 and 6 months after enrollment
Time frame: Up to 6 months after enrollment
SF-36 score at 1 month, 3 month and 6 month
Time frame: Up to 6 months after enrollment
GSRS score at 1 month, 3 month and 6 month
Time frame: Up to 6 months after enrollment
Other adverse events that occurred during the treatment
Time frame: Up to 6 months after enrollment
Survival status at study endpoints
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment
Time frame: Up to 6 months after enrollment.
Severity of the diarrhea
Time frame: Up to 6 months after enrollment
Involved organ response（kidney）at 3 and 6 months after enrollment
Time frame: Up to 6 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab and Bortezomib+Dexamethasone/Bortezomib+Dexamethasone+Daratumumab/single Daratumumab in people with Immunoglobulin Light-chain Amyloidosis, run by Air Force Military Medical University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiren Sun, Doctor (18520955728, 1019282726@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of diarrhea (time frame: Up to 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.