OsteoporosisSTARSNCT06389539
Synbiotic to Attenuate Resorption of the Skeleton
A study testing SBD111 medical food in people with Osteoporosis and Inflammation, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Inflammation, Aging
- What is being tested?
- SBD111 medical food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 38Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hebrew SeniorLife
Roslindale, Massachusetts, 02131
Kathryn Tasker, 617-971-5351, KathyTasker@hsl.harvard.edu
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss
This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.
Read the detailed description
There are currently no consistent guidelines on how middle aged and older adults can maintain healthy bone mass as they age. Hence, there is an unmet need for safe and effective dietary interventions for the metabolic processes underlying bone loss. The objective of this project, is to test the efficacy of a probiotic/prebiotic combination or synbiotic i.e. Solarea Bio defined microbial assemblage 111 (SBD111) medical food on the skeleton of older women.
Aim 1: To determine the effect of 18 months of daily intake of SBD111 medical food on the primary outcome of lumbar spine dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) and secondary outcomes (Biomechanical Computed Tomography analysis (BCT)-derived vertebral compressive strength, volumetric BMD (vBMD), and markers of bone turnover) in women.
Hypothesis 1a: BMD, vertebral compressive strength, and vBMD will be greater in women randomized to SBD111 medical food compared to placebo.
Hypothesis 1b: Biochemical markers of bone turnover will decrease with SBD111 medical food use compared to placebo.
Aim 2: To determine the effect of 18 months of daily intake of SBD111 medical food on markers of inflammation and gut microbiome function (secondary outcomes) in women.
Hypothesis 2a: Markers of inflammation [interleukin 17A (IL17A) and tumor necrosis factor alpha (TNF-α)] will be reduced with SBD111 medical food use compared to placebo.
Hypothesis 2b: Functional genes and pathways related to fiber breakdown (glycosyl hydrolases), menaquinone 7 production, and short chain fatty acid (SCFA) production, will be enriched in stool metagenomes and upregulated in stool metatranscriptomes from those receiving SBD111 medical food compared to placebo.
Eligible women will be randomized to SBD111 medical food versus placebo capsules for 18 months. Assessments will be made at the in-person baseline visit, 9-month and 18-month follow-up visits as well as monthly telephone calls.
The primary outcome is lumbar spine BMD (g/cm2) and secondary outcomes include vertebral compressive strength (N), vBMD (g/cm3), and bone biomarkers.
Intent-to-treat analysis will be conducted for all endpoints.
- Conditions
- Osteoporosis, Inflammation, Aging
- Being tested
- SBD111 medical food, Placebo
- Keywords
- Dietary probiotics, Dietary prebiotics, Gut microbiome, Older women, Randomized Controlled Trial
- Medical subject headings
- Osteoporosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBD111 medical foodOther
SBD111 medical food is a defined microbial assemblage (DMA) consisting of oligofructose and dried berry powder (prebiotics), a Pseudomonas fluorescens, a Lactobacillus brevis, a Leuconostoc mesenteroides, a Lactobacillus plantarum, and a Pichia kudriavzevii (yeast).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SBD111 medical food | Experimental | This group will receive SBD111 medical food capsules to be consumed over 18 months. Receives: Other: SBD111 medical food |
| Placebo | Placebo comparator | This group will receive placebo capsules to be consumed over 18 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine BMD (g/cm2)
BMD of the lumbar spine (L1-L4) will be measured at the baseline exam, 9-month, and 18-month final follow-up visit
Measured: Change over 18 months
Secondary outcomes (4)
Vertebral compressive strength (N)
Quantitative computed tomography (QCT) scans acquired at baseline and 18-months will be used to estimate vertebral compressive bone strength using Biomechanical Computed Tomography (BCT, VirtuOst, O.N. Diagnostics, Berkeley, CA).
Measured: Change over 18 months
volumetric BMD
Measurements of integral and vertebral trabecular vBMD at L1-L3.
Measured: Change over 18 months
C-terminal cross-linked telopeptide of type I collagen (β-CTX)
A biochemical marker of bone resorption
Measured: Change over 18 months
Procollagen Type I Intact N-terminal Propeptide (P1NP)
A biochemical marker of bone formation
Measured: Change over 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start12 Aug 2024
- Primary completionApr 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- Solarea Bio, Inc, Beth Israel Deaconess Medical Center, Tufts University, MaineHealth
- Responsible party
- Sponsor
- Investigators
- Shivani Sahni, PhD, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389539
- Sponsor's protocol ID
- Pro00070958
- Acronym
- STARS
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss
- ClinicalTrials.gov ID
- NCT06389539
- Acronym / sponsor ID
- STARS / Pro00070958
- Conditions
- Osteoporosis, Inflammation, Aging
- Keywords
- Dietary probiotics, Dietary prebiotics, Gut microbiome, Older women, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- Solarea Bio, Inc, Beth Israel Deaconess Medical Center, Tufts University, MaineHealth
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.
Detailed description
There are currently no consistent guidelines on how middle aged and older adults can maintain healthy bone mass as they age. Hence, there is an unmet need for safe and effective dietary interventions for the metabolic processes underlying bone loss. The objective of this project, is to test the efficacy of a probiotic/prebiotic combination or synbiotic i.e. Solarea Bio defined microbial assemblage 111 (SBD111) medical food on the skeleton of older women.
Aim 1: To determine the effect of 18 months of daily intake of SBD111 medical food on the primary outcome of lumbar spine dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) and secondary outcomes (Biomechanical Computed Tomography analysis (BCT)-derived vertebral compressive strength, volumetric BMD (vBMD), and markers of bone turnover) in women.
Hypothesis 1a: BMD, vertebral compressive strength, and vBMD will be greater in women randomized to SBD111 medical food compared to placebo.
Hypothesis 1b: Biochemical markers of bone turnover will decrease with SBD111 medical food use compared to placebo.
Aim 2: To determine the effect of 18 months of daily intake of SBD111 medical food on markers of inflammation and gut microbiome function (secondary outcomes) in women.
Hypothesis 2a: Markers of inflammation [interleukin 17A (IL17A) and tumor necrosis factor alpha (TNF-α)] will be reduced with SBD111 medical food use compared to placebo.
Hypothesis 2b: Functional genes and pathways related to fiber breakdown (glycosyl hydrolases), menaquinone 7 production, and short chain fatty acid (SCFA) production, will be enriched in stool metagenomes and upregulated in stool metatranscriptomes from those receiving SBD111 medical food compared to placebo.
Eligible women will be randomized to SBD111 medical food versus placebo capsules for 18 months. Assessments will be made at the in-person baseline visit, 9-month and 18-month follow-up visits as well as monthly telephone calls.
The primary outcome is lumbar spine BMD (g/cm2) and secondary outcomes include vertebral compressive strength (N), vBMD (g/cm3), and bone biomarkers.
Intent-to-treat analysis will be conducted for all endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months.
| Arm | Type | Receives |
|---|---|---|
| SBD111 medical food | Experimental | Other: SBD111 medical foodThis group will receive SBD111 medical food capsules to be consumed over 18 months. |
| Placebo | Placebo comparator | Other: PlaceboThis group will receive placebo capsules to be consumed over 18 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBD111 medical foodSBD111 medical food is a defined microbial assemblage (DMA) consisting of oligofructose and dried berry powder (prebiotics), a Pseudomonas fluorescens, a Lactobacillus brevis, a Leuconostoc mesenteroides, a Lactobacillus plantarum, and a Pichia kudriavzevii (yeast). | Other | SBD111 medical food |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Lumbar spine BMD (g/cm2)
Time frame: Change over 18 months
BMD of the lumbar spine (L1-L4) will be measured at the baseline exam, 9-month, and 18-month final follow-up visit
4 secondary outcomes
Vertebral compressive strength (N)
Time frame: Change over 18 months
volumetric BMD
Time frame: Change over 18 months
C-terminal cross-linked telopeptide of type I collagen (β-CTX)
Time frame: Change over 18 months
Procollagen Type I Intact N-terminal Propeptide (P1NP)
Time frame: Change over 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shivani Sahni, PhD principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBD111 medical food in people with Osteoporosis and Inflammation, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivani Sahni, PhD (617-971-5382, ShivaniSahni@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine BMD (g/cm2) (time frame: Change over 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.