Synbiotic to Attenuate Resorption of the Skeleton

Part of paid clinical trials in Roslindale, Massachusetts.

Sponsor
Hebrew SeniorLife
Study ID
NCT06389539
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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).
  • Placebo — OTHER
    Placebo

Study Details

This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.

Key Dates

Start date
Aug 12, 2024
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: SBD111 medical food
    This group will receive SBD111 medical food capsules to be consumed over 18 months.
  • Placebo Comparator: Placebo
    This group will receive placebo capsules to be consumed over 18 months.

Primary Outcome Measure

Lumbar spine BMD (g/cm2) [ Time Frame: Change over 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hebrew SeniorLifeRoslindaleMassachusetts02131
Kathryn Tasker
[email protected]
617-971-5351

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Hebrew SeniorLife· Roslindale, MA

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