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 range
60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.