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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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I have not used PTH, abaloparatide, romosozumab, denosumab, or coumadin in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change over 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change over 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lumbar spine BMD (g/cm2)

Secondary study objectives

C-terminal cross-linked telopeptide of type I collagen (β-CTX)

Procollagen Type I Intact N-terminal Propeptide (P1NP)

Vertebral compressive strength (N)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SBD111 medical foodExperimental Treatment1 Intervention

This group will receive SBD111 medical food capsules to be consumed over 18 months.

Group II: PlaceboPlacebo Group1 Intervention

This group will receive placebo capsules to be consumed over 18 months.

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor

46 Previous Clinical Trials

270,529 Total Patients Enrolled

15 Trials studying Aging

3,875 Patients Enrolled for Aging

Solarea Bio, IncIndustry Sponsor

4 Previous Clinical Trials

498 Total Patients Enrolled

Beth Israel Deaconess Medical CenterOTHER

859 Previous Clinical Trials

12,932,276 Total Patients Enrolled

3 Trials studying Aging

223 Patients Enrolled for Aging

Tufts UniversityOTHER

270 Previous Clinical Trials

594,671 Total Patients Enrolled

4 Trials studying Aging

235 Patients Enrolled for Aging

MaineHealthOTHER

74 Previous Clinical Trials

43,685 Total Patients Enrolled

1 Trials studying Aging

3,000 Patients Enrolled for Aging

Shivani Sahni, PhDPrincipal InvestigatorHebrew SeniorLife

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Aging

20 Patients Enrolled for Aging

~147 spots leftby Apr 2028

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