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Probiotic/Prebiotic Combination

Synbiotic Treatment for Osteoporosis (STARS Trial)

N/A

Waitlist Available

Led By Shivani Sahni, PhD

Research Sponsored by Hebrew SeniorLife

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 60 years and above

Normal renal function (eGFR >50 ml/min)

Must not have

History of bariatric surgery

History of partial colectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over 18 months

Summary

This trial will test if a combination of probiotics and prebiotics can improve bone health in older women.

Who is the study for?

This trial is for women over 60 with healthy vitamin D levels and normal kidney function, who haven't had certain surgeries or conditions that affect bone health. They should not be on specific medications, have a history of substance abuse, or plan to change their diet/exercise during the study.

What is being tested?

The trial tests a 'synbiotic' (a combo of probiotics and prebiotics) against a placebo to see if it helps maintain bone health in older women. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to allergies to synbiotic ingredients like probiotics, gelatin, rice, fruit extracts or berries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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My kidney function is normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I have had part of my colon removed.

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I am a woman with untreated high parathyroid hormone levels.

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I have taken supplements like fish oil or probiotics in the last month and can't stop for the study.

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I have a history of chronic liver disease, including Hepatitis B or C, cirrhosis, or NASH.

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I have a history of bone disorders like Paget's disease.

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I have had surgery on my colon or have a condition like ulcerative colitis, IBS, or Crohn's disease.

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I have not had major surgery or endoscopy in the last 3 months.

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My kidney function is low.

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I have had pancreas issues in the past.

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I have taken bisphosphonates in the last 3 years.

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I have had heart valve issues, endocarditis, or a valve replacement.

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I have had major fractures after turning 50 without major trauma.

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I have not had cancer (other than skin cancer), autoimmune diseases, immune issues like AIDS, type 2 diabetes, or serious gut problems in the last 5 years.

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I have a bone marrow problem like myelodysplastic syndrome or need blood transfusions for anemia.

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I haven't taken hormones or steroids in the last 6 months.

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