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

NCT07069751 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-03

No results posted yet for this study

Summary

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 in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will choose among a list of different diet plans or individual food according to the personal tastes and preference. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. As in line with routine diagnosis and follow-up of for patients affected by sMM, the investigators will collect bone marrow aspirates and peripheral blood at the time of screening, for plasma, serum, and peripheral blood mononuclear cells (PBMCs), while stool samples will be collected immediately before diet initiation. The investigators will also collect stool samples 4 and 12 weeks after diet initiation, and peripheral blood at 12 weeks after study initiation (as per routine clinical follow-up of this patient population). Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. Biological paired comparison will be conducted between data obtained from samples collected at time 0 and samples collected 4 and 12 weeks later.

Conditions

  • Smoldering Multiple Myeloma (SMM)

Interventions

DIETARY_SUPPLEMENT

diet rich in fiber

Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will also be encouraged to prolong plant-based diets beyond week 12. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. In particular, the patient will write for each day of the trial the number associated to the chosen diet plan or food.

Sponsors & Collaborators

  • Ciceri Fabio

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-06-30
Completion
2029-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069751 on ClinicalTrials.gov