NCT07069751Recruiting
A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- 31 Oct 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Ciceri Fabio
- Diseases
- Multiple myeloma
- NCT number
- NCT07069751
What you commit to
- Study type: Interventional
- Planned participants: 62
- From 31 Oct 2025 to the primary completion date, 30 Jun 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet.
- Concurrent pregnancy.
- Current self-reported illicit drug use (e.g., heroin, cocaine not marijuana).
- Subjects reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy, or prophylaxis. Antibiotic therapy dramatically modifies the composition of the gut microbiota.
Other illness
- Non-Caucasian subjects. Racial disparities in all stages of the disease characterize MM, and Blacks have an increased MGUS and MM risk and higher mortality rate than Whites.
- Legume allergy.
- Severe allergies such as anaphylactic shock to nuts (specifically cashews).
- Ongoing treatment for HBV, HCV or HIV.
- Subjects affected by autoimmune diseases except for thyroiditis, and patients affected by small and large intestine dysfunctions (i.e., inflammatory bowel disease).
- Gammopathy-associated conditions beyond sMM (e.g. amiloydosis, POEMS, LCDD, etc).
Other
- Patients that already follow a whole food plant-based diet (≥ 40g/die;ovo-lacto-vegetarian or processed junk food vegan diets are not excluded). These patients likely should already have high SCFA levels in their gut.
- Enrollment onto any other therapeutic investigational study.
- If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.
- Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week).
- Subjects that did not accept to sign the informed consent.
Who the study is looking for
- 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
- Participant is willing to comply with all study-related procedures.
- ECOG performance status of 0-1.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Giovanni XXIII Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.