Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
220 participants
INTERVENTIONAL
2024-08-12
2028-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SBD111 medical food
This group will receive SBD111 medical food capsules to be consumed over 18 months.
SBD111 medical food
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).
Placebo
This group will receive placebo capsules to be consumed over 18 months.
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SBD111 medical food
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).
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 with use of osteoporosis medications for the entire duration of their participation in the study.
5. 25-hydroxy vitamin D ≥ 20 ng/mL
6. Normal renal function (eGFR \>50 ml/min)
7. Have chosen to not accept the standard of care with use of osteoporosis medications for the duration of the study.
8. Willing to comply with protocol and report on compliance and side effects during study period.
Exclusion Criteria
2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and and unwilling to avoid these supplements for the duration of the study.
3. Known or suspected allergies to probiotics, gelatin, rice, edible fruit extract or berries.
4. We will exclude women using antibiotics in the past 3 months but those placed on an antibiotic after enrollment, will be retained.
5. History of drug and/or alcohol abuse at the time of enrolment.
6. Presence of any of the following:
1. History of other bone disorders (e.g. Paget's disease)
2. History of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years
3. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes, gastrointestinal disorders (ulcerative colitis, inflammatory bowel disease)
4. 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
5. Women with untreated hyperparathyroidism
6. History of chronic antibiotic use
7. History of bariatric surgery
8. History of partial colectomy
9. History of problems with pancreas
10. History of history of chronic Hepatitis B or Hepatitis C, cirrhosis, fatty liver (nonalcoholic steatohepatitis; NASH) or chronic liver disease
11. History of problems with your heart valves, endocarditis, or previously had a valve replacement
12. Currently have problems with bone marrow such as myelodysplastic syndrome or anemia requiring transfusions
13. Women with spine abnormalities that would interfere with the assessment of BMD
14. Current smoking or use of nicotine products within the past 6-months
15. Major surgery or endoscopy within last 3 months
16. Coloscopy planned in the next 18-months and unwilling to reschedule it
17. Indwelling catheter, implanted hardware/prosthetic device or feeding tube
18. Any medical condition that could interfere with the conduct of the study
7. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months
8. Treatment with bisphosphonates in the past 3 yrs
9. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use.
10. 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.
11. Participants who plan on changing diet and/or exercise regime during trial participation.
12. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):
* 25-hydroxy vitamin D \<20 ng/mL
* Renal dysfunction (eGFR ≤50 ml/min)
13. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic BP greater than equal to 100mm Hg.
14. Short Blessed Test score \>10 or judged by the research staff as unable to follow the study protocol
15. Current treatment or previous with Glucagon-like peptide (GLP-1) agonists in the last one year.
16. 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.
60 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Solarea Bio, Inc
INDUSTRY
Beth Israel Deaconess Medical Center
OTHER
Tufts University
OTHER
MaineHealth
OTHER
Hebrew SeniorLife
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shivani Sahni, PhD
Role: PRINCIPAL_INVESTIGATOR
Hebrew SeniorLife
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hebrew SeniorLife
Roslindale, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kathryn Tasker
Role: primary
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00070958
Identifier Type: -
Identifier Source: org_study_id