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

ID studio #: NCT05776940

condizione: Immunoglobulin Light-chain Amyloidosis

stato: Non ancora reclutamento

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.

intervento: 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

risultati: https://clinicaltrials.gov/ct2/show/results/NCT05776940

ultimo aggiornamento: Dicembre 28, 2023

fase di sviluppo: Fase 3

taglia / iscrizione: 116

risultati primari:

• Occurrence of diarrhea
  Increased stool frequency and/or loose or watery stools
• Up to 3 months after enrollment
  

risultati secondari:

• Time before diarrhea
  Up to 3 months after enrollment
• Duration of the diarrhea
  Up to 6 months after enrollment
• Hematological response at 3 and 6 months after enrollment
  Up to 6 months after enrollment
• Involved organ response（heart）at 3 and 6 months after enrollment
  Up to 6 months after enrollment
• SF-36 score at 1 month, 3 month and 6 month
  Up to 6 months after enrollment
• GSRS score at 1 month, 3 month and 6 month
  Up to 6 months after enrollment
• Other adverse events that occurred during the treatment
  Up to 6 months after enrollment
• Survival status at study endpoints
  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
  Up to 6 months after enrollment.
• Severity of the diarrhea
  Up to 6 months after enrollment
• Involved organ response（kidney）at 3 and 6 months after enrollment
  Up to 6 months after enrollment

criterio di inclusione:

criteri di esclusione: criteri:

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

sedi dei centri di prova: