Osteoporosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 60 years or older.
• People who have given written consent to take part and are available and willing to follow the study requirements for the entire study period.
• People whose bone density scan (DXA) of the hip and spine shows a T-score above -2.5 (meaning bone density is not in the osteoporosis range).
• People with a T-score of -2.5 or lower (indicating osteoporosis) may also be considered, as long as they have decided not to take standard osteoporosis medications for the duration of the study.
• People who have had a serious broken bone from a minor injury (such as a hip, wrist, upper arm, or spine fracture) since age 50 may be considered, provided they are not currently taking osteoporosis medications and have decided not to do so for the study period, even if osteoporosis is diagnosed during screening.
• People whose blood vitamin D level is at or above 20 ng/mL.
• People whose kidneys are functioning well enough (confirmed by a blood test showing eGFR above 50 ml/min).
• People who have decided not to use standard osteoporosis medications for the length of the study.
• People who are willing to follow the study protocol and report on how well they are following it, as well as any side effects they experience.

Who may not be able to join:

• People with a body mass index (BMI) over 40.
• People who have taken dietary supplements such as fish oil, probiotics, prebiotics, or fibre supplements in the past month and are not willing to stop taking them for the duration of the study.
• People who use osmotic laxatives more than once a week and are not willing to stop for the duration of the study.
• People with known or suspected allergies to probiotics, rice, edible fruit extract, or berries.
• People who have used antibiotics in the past 3 months (note: people who need antibiotics after joining the study may be able to remain in the trial — confirm with trial site).
• People with a current or recent history of drug or alcohol misuse at the time of enrolment.
• People with a history of other bone disorders, such as Paget's disease.
• People with a history of moderate to severe scoliosis (abnormal spinal curvature).
• People with a history of cancer (other than skin cancer that has been in remission for less than 5 years), autoimmune disease, immune system problems such as AIDS, or type 1 or type 2 diabetes.
• People with a history of colon removal, or conditions that affect the gut lining such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, or any other ongoing bowel condition.
• Women with untreated overactive parathyroid glands (hyperparathyroidism).
• People with a history of long-term antibiotic use.
• People who have had bariatric (weight loss) surgery.
• People who have had part of their colon removed (partial colectomy).
• People with a history of pancreatic disease.
• People with a history of active hepatitis B, hepatitis C, cirrhosis, fatty liver disease, or any chronic liver disease.
• People with current bone marrow disorders such as myelodysplastic syndrome or anaemia requiring blood transfusions.
• People whose spine has abnormalities that the study doctor determines would interfere with measuring bone density.
• People who currently smoke or have used nicotine products in the past 6 months.
• People who currently use marijuana and are not willing to stop during the study.
• People who have had major abdominal surgery in the past 3 months.
• People who have had a colonoscopy in the past month.
• People who have a colonoscopy planned in the next 18 months and are not willing to reschedule it.
• People who have an indwelling catheter, implanted device or prosthetic hardware, or a feeding tube.
• People with any medical condition that the study team determines could interfere with the conduct of the study.
• People who have used certain bone or hormone-related medications — including calcitonin, oestrogens, selective oestrogen receptor modulators, progestins, anabolic steroids, or glucocorticoids — in the past 6 months.
• People who have used bisphosphonate medications (a common class of osteoporosis drugs) in the past 3 years.
• People who have previously used parathyroid hormone (PTH), abaloparatide, romosozumab, or denosumab in the past year, or who are currently using the blood-thinning medication coumadin (warfarin).
• People who have used GLP-1 receptor agonist medications (a type of medication used for diabetes or weight management) in the past year.
• People who have taken part in other clinical trials related to bone, diet, autoimmune conditions, or gut health in the past 6 months, or whose most recent experimental trial ended less than 60 days ago.
• People who plan to change their diet or exercise habits during the study.
• People whose blood test results fall outside the normal range — specifically a vitamin D level below 20 ng/mL or a kidney function result (eGFR) at or below 50 ml/min.
• People with a seated blood pressure of 160 mmHg or higher (top number) or 100 mmHg or higher (bottom number).
• People who score above 10 on a brief memory and thinking assessment called the Short Blessed Test, or who the research team judges to be unable to follow the study requirements.
• People with any other condition that, in the opinion of the study doctor or clinician, could put the participant at risk or make it unlikely they could complete the study.

Important: Always verify eligibility with the trial site directly before applying.