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

Immunoglobulin Light-chain Amyloidosis Clinical Trial

Official title:

Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05776940
• Other study ID #: Probiotic in AL amyloidosis
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2023
• Source: Air Force Military Medical University, China
• Contact: Shiren Sun, Doctor
• Phone: 18520955728
• Email: 1019282726[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of diarrhea	Increased stool frequency and/or loose or watery stools	Up to 3 months after enrollment
Secondary	Time before diarrhea	Time interval from the start of treatment to the first diarrhea	Up to 3 months after enrollment
Secondary	Duration of the diarrhea	The time between the start of diarrhea and the last diarrhea.	Up to 6 months after enrollment
Secondary	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.	Up to 6 months after enrollment
Secondary	Involved organ response(heart)at 3 and 6 months after enrollment	Involved organ response(heart)is evaluated according to the change of NT-proBNP.	Up to 6 months after enrollment
Secondary	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.	Up to 6 months after enrollment
Secondary	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.	Up to 6 months after enrollment
Secondary	Other adverse events that occurred during the treatment	Adverse events are evaluated according to the CTCAE 5.0.	Up to 6 months after enrollment
Secondary	Survival status at study endpoints	Survival status(live or dead)	From date of randomization until the date of death from any cause, assessed up to 36 months
Secondary	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 a-diversity and ß-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.
Secondary	Severity of the diarrhea	The severity of diarrhea was graded according to the CTCAE 5.0.	Up to 6 months after enrollment
Secondary	Involved organ response(kidney)at 3 and 6 months after enrollment	Involved organ response(kidney)is evaluated according to the change of 24h proteinuria.	Up to 6 months after enrollment