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

March 18, 2023 updated by: Shiren sun, Air Force Military Medical University, China

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic group
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: 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).
Other Names:
  • Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules + Routine therapy
Active Comparator: Control group
Naive al amyloidosis patients receive Bortezomib+Dexamethasone, Bortezomib+Dexamethasone+Daratumumab or single Daratumumab therapy without any probiotics.
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).
Other Names:
  • Routine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of diarrhea
Time Frame: Up to 3 months after enrollment
Increased stool frequency and/or loose or watery stools
Up to 3 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time before diarrhea
Time Frame: Up to 3 months after enrollment
Time interval from the start of treatment to the first diarrhea
Up to 3 months after enrollment
Duration of the diarrhea
Time Frame: Up to 6 months after enrollment
The time between the start of diarrhea and the last diarrhea.
Up to 6 months after enrollment
Hematological response at 3 and 6 months after enrollment
Time Frame: Up to 6 months after enrollment
Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis.
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
Involved organ response（heart）is evaluated according to the change of NT-proBNP.
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
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.
Up to 6 months after enrollment
GSRS score at 1 month, 3 month and 6 month
Time Frame: Up to 6 months after enrollment
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.
Up to 6 months after enrollment
Other adverse events that occurred during the treatment
Time Frame: Up to 6 months after enrollment
Adverse events are evaluated according to the CTCAE 5.0.
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
Survival status（live or dead）
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.
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.)
Up to 6 months after enrollment.
Severity of the diarrhea
Time Frame: Up to 6 months after enrollment
The severity of diarrhea was graded according to the CTCAE 5.0.
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
Involved organ response（kidney）is evaluated according to the change of 24h proteinuria.
Up to 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 31, 2023

Primary Completion (Anticipated)

March 31, 2026

Study Completion (Anticipated)

March 31, 2026

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 18, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 18, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Probiotic in AL amyloidosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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