Synbiotic to Attenuate Resorption of the Skeleton

NCT06389539 | Recruiting DMC

• 1 other identifier: Pro00070958
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Aging; Osteoporosis

Keywords

Dietary probiotics; Dietary prebiotics; Gut microbiome; Older women; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

  Change over 18 months

Secondary Outcomes (4)

• Vertebral compressive strength (N)

  Change over 18 months

• volumetric BMD

  Change over 18 months

• C-terminal cross-linked telopeptide of type I collagen (β-CTX)

  Change over 18 months

• Procollagen Type I Intact N-terminal Propeptide (P1NP)

  Change over 18 months

Study Arms (2)

SBD111 medical food

EXPERIMENTAL

This group will receive SBD111 medical food capsules to be consumed over 18 months.

Other: SBD111 medical food

Placebo

PLACEBO COMPARATOR

This group will receive placebo capsules to be consumed over 18 months.

Other: Placebo

Interventions

Placebo OTHER

Placebo

Placebo

SBD111 medical food OTHER

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).

SBD111 medical food

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Provided written informed consent.
• \. Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
• \. Age 60 years and above.
• \. 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.
• \. 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.
• \. Serum 25-hydroxyvitamin D ≥ 20 ng/mL.
• \. Normal renal function (eGFR \>50 ml/min).
• \. Have chosen to not accept the standard of care use of osteoporosis medications for the duration of the study.
• \. Willing to comply with protocol and report on compliance and side effects during the study period.

You may not qualify if:

• \. BMI greater than 40 kg/m2.
• \. 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.
• \. Participants using osmotic laxatives \>1 per week and unwilling to avoid use for the duration of the study.
• \. Known or suspected allergies to probiotics, rice, edible fruit extract or berries.
• \. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained.
• \. History of drug and/or alcohol abuse at the time of enrolment.
• \. 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.

Sponsors & Collaborators

• Solarea Bio, Inc: collaborator
• Hebrew SeniorLife: lead
• Beth Israel Deaconess Medical Center: collaborator
• Tufts University: collaborator
• MaineHealth: collaborator

Study Sites (1)

Hebrew SeniorLife

Roslindale, Massachusetts, 02131, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Inflammation

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shivani Sahni, PhD

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Sahni, PhD

CONTACT

617-971-5382; ShivaniSahni@hsl.harvard.edu

Evelyn O'Neill

CONTACT

617-697-6599; oneill@hsl.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study staff involved in participants' outcome assessments will be masked to the intervention assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)