Synbiotic to Attenuate Resorption of the Skeleton (NCT06389539) | Clinical Trial Compass
RecruitingNot Applicable
Synbiotic to Attenuate Resorption of the Skeleton
United States220 participantsStarted 2024-08-12
Plain-language 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.
Who can participate
Age range60 Years
SexFEMALE
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Inclusion Criteria:
* 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.
* 5\. 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.
* 6\. Serum 25-hydroxyvitamin D ≥ 20 ng/mL.
* 7\. Normal renal function (eGFR \>50 ml/min).
* 8\. Have chosen to not accept the standard of care use of osteoporosis medications for the duration of the study.
* 9\. Willing to comply with protocol and report on compliance and side effects during the study period.
Exclusion Criteria:
* 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…