Synbiotic to Attenuate Resorption of the Skeleton

Last updated: February 4, 2025
Sponsor: Hebrew SeniorLife
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Osteoporosis

Aging

Treatment

SBD111 medical food

Placebo

Clinical Study ID

NCT06389539
Pro00070958
  • Ages > 60
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provide written informed consent

  2. Stated availability throughout entire study period and willingness to fulfill alldetails 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 havedecided not to accept the standard of care with use of osteoporosis medications forthe 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 medicationsfor the duration of the study.

  8. Willing to comply with protocol and report on compliance and side effects duringstudy period.

Exclusion

Exclusion Criteria:

  1. BMI greater than equal to 35 kg/m2.

  2. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, andfiber) in the prior month, and and unwilling to avoid these supplements for theduration of the study.

  3. Known or suspected allergies to probiotics, gelatin, rice, edible fruit extract orberries.

  4. We will exclude women using antibiotics in the past 3 months but those placed on anantibiotic 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:

  7. History of other bone disorders (e.g. Paget's disease)

  8. History of major low-trauma fragility fractures (hip, forearm, humerus, spine)since the age of 50 years

  9. History of cancer other than skin cancer <5 years in remission, autoimmunedisease, immune problems such as AIDS, type 1 or 2 diabetes, gastrointestinaldisorders (ulcerative colitis, inflammatory bowel disease)

  10. History of colon resection, any disease that could interfere with theintestinal barrier function such as ulcerative colitis, irritable bowelsyndrome or Crohn's disease

  11. Women with untreated hyperparathyroidism

  12. History of chronic antibiotic use

  13. History of bariatric surgery

  14. History of partial colectomy

  15. History of problems with pancreas

  16. History of history of chronic Hepatitis B or Hepatitis C, cirrhosis, fattyliver (nonalcoholic steatohepatitis; NASH) or chronic liver disease

  17. History of problems with your heart valves, endocarditis, or previously had avalve replacement

  18. Currently have problems with bone marrow such as myelodysplastic syndrome oranemia requiring transfusions

  19. Women with spine abnormalities that would interfere with the assessment of BMD

  20. Current smoking or use of nicotine products within the past 6-months

  21. Major surgery or endoscopy within last 3 months

  22. Coloscopy planned in the next 18-months and unwilling to reschedule it

  23. Indwelling catheter, implanted hardware/prosthetic device or feeding tube

  24. Any medical condition that could interfere with the conduct of the study

  25. Treatment with calcitonin, estrogens, selective estrogen receptor modulators,progestins, anabolic steroids, or glucocorticoids in the past 6 months

  26. Treatment with bisphosphonates in the past 3 yrs

  27. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab ordenosumab in the last year or current coumadin use.

  28. Participation in other bone, diet, autoimmune, or GI related clinical trials in thelast 6 months. If the subject has been in a recent experimental trial, these musthave been completed not less than 60 days prior to this study.

  29. Participants who plan on changing diet and/or exercise regime during trialparticipation.

  30. Screening laboratory tests greater than upper normal limit (ULN) or less than lowernormal limit (LLN):

  • 25-hydroxy vitamin D <20 ng/mL

  • Renal dysfunction (eGFR ≤50 ml/min)

  1. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic BP greaterthan equal to 100mm Hg.

  2. Short Blessed Test score >10 or judged by the research staff as unable to follow thestudy protocol

  3. Current treatment or previous with Glucagon-like peptide (GLP-1) agonists in thelast one year.

  4. Any other condition that in the opinion of the investigator or study clinician wouldjeopardize the safety or rights of the volunteer participating in the study or wouldmake it unlikely the volunteer could complete the study.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: SBD111 medical food
Phase:
Study Start date:
August 12, 2024
Estimated Completion Date:
April 30, 2028

Study 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.

Connect with a study center

  • Hebrew SeniorLife

    Roslindale, Massachusetts 02131
    United States

    Active - Recruiting

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