Clinical trial for Osteoporosis
Official title Synbiotic to Attenuate Resorption of the Skeleton
ClinicalTrials.gov ID: NCT06389539
What this study is testing
- What it's testing
- This study is testing whether a synbiotic can protect bone health in older women.
- Who it's for
- You may be able to join if you are an older woman with osteoporosis or at risk for bone loss.
- What's involved
- You will take a daily capsule that contains friendly bacteria and fiber. You will also have bone scans and blood tests at the start and during the study.
- Time commitment
- The study lasts about 12 months, with visits at the start, 6 months, and 12 months.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only. Healthy volunteers may be eligible.
You may be able to join 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.
- 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...
You likely can't join 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
What rules you out
- 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.
- 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.
- s. Any medical condition that could interfere with the conduct of the study.
- 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.
- 13\. Participants who plan on changing diet and/or exercise regime during trial participation.
- Serum 25-hydroxyvitamin D \<20 ng/mL
- Renal dysfunction (eGFR ≤50 ml/min)
- 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.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Roslindale, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Roslindale, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.