MedTrace Logo

Synbiotic to Attenuate Resorption of the Skeleton

NCT06389539 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-03-17

No results posted yet for this 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.

Conditions

Interventions

OTHER

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).

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Solarea Bio, Inc

    collaborator INDUSTRY

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Tufts University

    collaborator OTHER

  • MaineHealth

    collaborator OTHER

  • Hebrew SeniorLife

    lead OTHER

Principal Investigators

  • Shivani Sahni, PhD · Hebrew SeniorLife

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2028-04-30
Completion
2029-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389539 on ClinicalTrials.gov