Fiber-Rich diet may alter gut bacteria in early myeloma
NCT ID NCT07069751
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether eating a high-fiber, plant-based diet for 12 weeks can change the gut bacteria in people with smoldering multiple myeloma (SMM), a condition that can sometimes turn into active myeloma. Researchers will measure short-chain fatty acids (SCFAs) in stool and track changes in the microbiome. Up to 62 participants will follow a fiber-rich diet and provide stool and blood samples over 12 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ≥18 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 (≥ 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliero Universitaria di Parma
NOT_YET_RECRUITINGParma, Italy
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITINGMilan, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori
NOT_YET_RECRUITINGMilan, Italy
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IRCCS Ospedale San Raffaele
RECRUITINGMilan, Milano, 20132, Italy
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Ospedale Giovanni XXIII Policlinico di Bari
NOT_YET_RECRUITINGBari, Italy
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Other studies related to the condition(s) this trial covers.
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- Scientists hunt for clues to predict who will develop bone marrow cancer
- Can a drug nip myeloma in the bud? new trial aims to stop cancer before it starts
- Can a single drug hold off multiple myeloma? new trial aims to find out