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Could a Once-Daily probiotic help bones? new trial begins

NCT ID NCT07538167

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new once-daily version of a probiotic food (SBD111) works as well as the current twice-daily version in healthy adults aged 35 and older. The goal is to see if the new formula leads to similar levels of helpful gut microbes. Participants take capsules for 28 days and provide stool samples at home.

What this could mean

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

Active substance
SBD111 (probiotic bacteria, yeast, and prebiotic fibers)
What this could lead to
If successful, this could lead to a more convenient once-daily probiotic food for managing bone loss after menopause.
What could go wrong
This is an early-stage trial focused on gut microbe levels, not bone health directly. The new formula may not work as well as the current one, and results may not apply to people with osteoporosis.

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 80 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Anyone

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:• Provide written informed consent. * Stated availability throughout entire study period and willingness to fulfill all details of the protocol. * Age 35 years or older. * Be in general good health as determined by a screening evaluation within 30 days of the first administration of SBD111 medical foods. * Willing to comply with protocol and report on compliance and side effects during study period. * Body Mass Index between 18.5 and 40kg/m2. Exclusion Criteria: * • Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days. If participant is willing to stop taking probiotic or prebiotic supplement for 30-days, they can be re-screened for eligibility and enrollment after consent. * Unwilling to avoid probiotics/prebiotics supplements for the duration of the study. * Known or suspected allergies to probiotics, maltodextrin, or berries. * Received oral or parenteral antibiotics within 30 days of enrollment or prescribed antibiotics on the day of enrollment. * Major surgery on the intestines or endoscopy within last 3 months. * History of drug and/or alcohol abuse at the time of enrollment. * Presence of any of the following based on participant reported health history: * Clinically significant systems abnormalities based on screening questionnaire. * Indwelling catheter or feeding tube. * Febrile illness (oral temperature \>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first administration of study article). * Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease. * History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease. * Underlying structural heart disease or previous history of endocarditis or valve replacement. * Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy. * History of Celiac disease. * History of cancer. a. Excluding non-melanoma skin cancers or cancer more than 10 years ago. * History of autoimmune disease and taking any immunosuppressant drugs. * Active tuberculosis. * Pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first administration of DMA. * Participants may be excluded if, in the investigator's opinion, there is evidence of cognitive impairment or dementia which is sufficient to interfere with informed consent or adherence to the study protocol. Four questions will be asked during the informed consent process to confirm participant's understanding and ability to comply. (See section 8.3) * Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study. * Bowel movement frequency less than one per 36-hour period. * If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic osteoporosis

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 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.