AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 75 YearsAllCiceri Fabio
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Confirmed diagnosis of sMM according to IMWG criteria 3. Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events). 4. Aged โ‰ฅ18 and \</= 75 years 5. Participant is willing to comply with all study-related procedures. 6. ECOG performance status of 0-1. Exclusion Criteria: 1. 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. 2. Patients that already follow a whole food plant-based diet (โ‰ฅ 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. 3. Legume allergy. 4. Severe allergies such as anaphylactic shock to nuts (specifically cashews). 5. Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet. 6. Enrollment onto any other therapeutic investigational study. 7. Concurrent pregnancy. 8. Ongoing treatment for HBV, HCV or HIV. 9. 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. 10. Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week). 11. Current self-reported illicit drug use (e.g., heroin, cocaine not marijuana). 12. Subjects that did not accept to sign the informed consent. 13. 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. 14. Subjects affected by autoimmune diseases except for thyroiditis, and patients affected by small and large intestine dysfunctions (i.e., inflammatory bowel disease). 15. Gammopathy-associated conditions beyond sMM (e.g. amiloydosis, POEMS, LCDD, etc).
๐Ÿ’Š

What it tests

  • diet rich in fiber
๐Ÿ“

Where

5 sites
IRCCS Ospedale San Raffaele
Milan, Italy
Ospedale Giovanni XXIII Policlinico di Bari
Bari, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy