Could a probiotic drink strengthen aging bones?

NCT ID NCT06389539

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a special medical food containing probiotics and prebiotics to see if it can help slow or reverse bone loss in older women. Researchers will measure changes in bone density and strength over 18 months. The goal is to find a safe, dietary approach to manage osteoporosis without traditional medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SBD111 medical food (a mix of prebiotics and probiotics including specific bacteria and yeast)
What this could lead to
If it works, this could offer a natural, non-drug option to help manage bone loss and reduce fracture risk in older women.
What could go wrong
This is an early-stage trial with 220 participants, so results may not apply to everyone. The effect on bone density may be small or not clinically meaningful.

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 220 people

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

Started

Aug 2024

Expected to finish

Mar 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

60 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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\. Provided written informed consent. * 2\. Stated availability throughout entire study period and willingness to fulfill all details of the protocol. * 3\. Age 60 years and above. * 4\. DXA-BMD of the hip and spine (T-score) \> -2.5. Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care use of osteoporosis medications for the entire duration of their participation in the study. * 5\. Women with a history of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years will be considered if they are not currently using osteoporosis medications, or if they have decided not to accept the standard of care osteoporosis medications, even if diagnosed with osteoporosis during the screening procedure. * 6\. Serum 25-hydroxyvitamin D ≥ 20 ng/mL. * 7\. Normal renal function (eGFR \>50 ml/min). * 8\. Have chosen to not accept the standard of care use of osteoporosis medications for the duration of the study. * 9\. Willing to comply with protocol and report on compliance and side effects during the study period. Exclusion Criteria: * 1\. BMI greater than 40 kg/m2. * 2\. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and unwilling to avoid these supplements for the duration of the study. * 3\. Participants using osmotic laxatives \>1 per week and unwilling to avoid use for the duration of the study. * 4\. Known or suspected allergies to probiotics, rice, edible fruit extract or berries. * 5\. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained. * 6\. History of drug and/or alcohol abuse at the time of enrolment. * 7\. Presence of any of the following: * a. History of other bone disorders (e.g. Paget's disease). * b. History of moderate to severe scoliosis. * c. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes. * d. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease or any chronic bowel condition. * e. Women with untreated hyperparathyroidism. * f. History of chronic antibiotic use. * g. History of bariatric surgery. * h. History of partial colectomy. * i. History of pancreatic disease. * j. History of active hepatitis B, hepatitis C, cirrhosis, metabolic dysfunction-associated steatotitc liver disease (MASLD), fatty liver or chronic liver disease. * k. Current bone marrow disorders such as myelodysplastic syndrome or anemia requiring transfusions. * l. Abnormalities of the spine determined by the study physician to interfere with the assessment of bone mineral density. * m. Current smoking or use of nicotine products within the past 6 months. * n. Current use of marijuana and unwilling to abstain during the study period. * o. Major abdominal surgery within the last 3 months. * p. Colonoscopy within the last 1 month. * q. Colonoscopy planned in the next 18 months and unwilling to reschedule it. * r. Indwelling catheter, implanted hardware/prosthetic device or feeding tube. * s. Any medical condition that could interfere with the conduct of the study. * 8\. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months. * 9\. Treatment with bisphosphonates in the past 3 years. * 10\. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use. * 11\. Current or previous treatment with glucagon-like peptide (GLP-1) receptor agonists in the last one year. * 12\. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study. * 13\. Participants who plan on changing diet and/or exercise regime during trial participation. * 14\. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN): * Serum 25-hydroxyvitamin D \<20 ng/mL * Renal dysfunction (eGFR ≤50 ml/min) * 15\. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic blood pressure greater than equal to 100mm Hg. * 16\. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol. * 17\. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

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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

    1 site. 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

  • Hebrew SeniorLife

    RECRUITING

    Roslindale, Massachusetts, 02131, United States

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