Tests a probiotic and prebiotic food for age-related bone loss in older women

Trial details

Who runs it

Hebrew SeniorLife

Trial code

NCT06389539

Record updated

17 March 2026

Original description

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

A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss

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

Inclusion: 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: 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; o. Major abdominal surgery within the last 3 months; 8. Treatment with calcitonin, estrogens, selective estrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids in the past 6 months; 9. Treatment with bisphosphonates in the past 3 years; 10. Previous treatment with parathyroid hormone (PTH), abaloparatide, romosozumab or denosumab in the last year or current coumadin use; 11. Current or previous treatment with glucagon-like peptide (GLP-1) receptor agonists in the last one year; 12. Participation in other bone, diet, autoimmune, or GI related clinical trials in the last 6 months. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study; 4. Known or suspected allergies to probiotics, rice, edible fruit extract or berries; 6. History of drug and/or alcohol abuse at the time of enrolment; a. History of other bone disorders (e.g. Paget's disease); b. History of moderate to severe scoliosis; d. History of colon resection, any disease that could interfere with the intestinal barrier function such as ulcerative colitis, irritable bowel syndrome or Crohn's disease or any chronic bowel condition; f. History of chronic antibiotic use; g. History of bariatric surgery; h. History of partial colectomy; i. History of pancreatic disease; j. History of active hepatitis B, hepatitis C, cirrhosis, metabolic dysfunction-associated steatotitc liver disease (MASLD), fatty liver or chronic liver disease; k. Current bone marrow disorders such as myelodysplastic syndrome or anemia requiring transfusions; s. Any medical condition that could interfere with the conduct of the study; 17. Any other condition that in the opinion of the investigator or study clinician would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study; 14. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):; Serum 25-hydroxyvitamin D <20 ng/mL; Renal dysfunction (eGFR ≤50 ml/min); c. History of cancer other than skin cancer <5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes; 1. BMI greater than 40 kg/m2; 3. Participants using osmotic laxatives >1 per week and unwilling to avoid use for the duration of the study; 5. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained; 7. Presence of any of the following:; e. Women with untreated hyperparathyroidism; l. Abnormalities of the spine determined by the study physician to interfere with the assessment of bone mineral density; m. Current smoking or use of nicotine products within the past 6 months; n. Current use of marijuana and unwilling to abstain during the study period; p. Colonoscopy within the last 1 month; q. Colonoscopy planned in the next 18 months and unwilling to reschedule it; r. Indwelling catheter, implanted hardware/prosthetic device or feeding tube; 13. Participants who plan on changing diet and/or exercise regime during trial participation; 15. Seated blood pressure greater than equal to 160 mm Hg or seated diastolic blood pressure greater than equal to 100mm Hg; 16. Short Blessed Test score >10 or judged by the research staff as unable to follow the study protocol.

ClinicalTrials.gov NCT06389539