Synbiotic to Attenuate Resorption of the Skeleton
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorHebrew SeniorLife
About this trial
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
Qualifiers
1. Provided written informed consent.
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 use of osteoporosis medications for the entire duration of their participation in the study.
Disqualifiers
1. BMI greater than 40 kg/m2.
2. 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.
3. Participants using osmotic laxatives >1 per week and unwilling to avoid use for the duration of the study.
4. Known or suspected allergies to probiotics, rice, edible fruit extract or berries.
Trial design
Treatments tested in this trial
- SBD111 medical food
- Placebo
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hebrew SeniorLife
Lead sponsor
Solarea Bio, Inc
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Tufts University
Collaborator
MaineHealth
Collaborator
Source ClinicalTrials.gov