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Fiber-Rich diet may alter gut bacteria in early myeloma

NCT ID NCT07069751

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Azienda Ospedaliero Universitaria di Parma

    NOT_YET_RECRUITING

    Parma, Italy

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Milano, 20132, Italy

  • Ospedale Giovanni XXIII Policlinico di Bari

    NOT_YET_RECRUITING

    Bari, Italy

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