Synbiotic to Attenuate Resorption of the Skeleton

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Osteoporosis, Inflammation, Aging

In brief

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

Key facts

Study ID: NCT06389539
Run by: Hebrew SeniorLife
People needed: 220
Starts: 2024-08-12
Expected to finish: 2029-03-01
Last updated by the study team: 2026-03-17

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.
5. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained.
6. History of drug and/or alcohol abuse at the time of enrolment.
7. Presence of any of the following:
a. History of other bone disorders (e.g. Paget's disease).
b. History of moderate to severe scoliosis.
c. History of cancer other than skin cancer <5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes.
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.
e. Women with untreated hyperparathyroidism.
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.
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.
o. Major abdominal surgery within the last 3 months.
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.

Where it is running

Hebrew SeniorLife — Roslindale, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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