A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma

Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8/Th17 ratio in sMM patients, thus preventing evolution to MM. Goal of this national, prospective, multicenter study is to demonstrate that plant-based diets substantially modify the gut microbiome inducing increased production of SCFAs in patients affected by sMM. The study will involve up to 62 patients affected by sMM. 56 Enrolled and eligible patients will be encouraged to consume a balanced diet rich

Trial Details

NCT ID
NCT07069751
Phase
NA
Sponsor
Ciceri Fabio
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • diet rich in fiber
Locations (sample)
  • Milan, Milano, Italy|42.78235,12.59836
  • Bari, Italy|41.12066,16.86982
  • Milan, Italy|42.78235,12.59836
  • Milan, Italy|42.78235,12.59836
  • Parma, Italy|44.79935,10.32618

Key Eligibility Criteria

  • Participant is willing and able to give informed consent for participation in the study.
  • Confirmed diagnosis of sMM according to IMWG criteria
  • Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).
  • Aged ≥18 and \</= 75 years

For full eligibility, visit ClinicalTrials.gov.

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