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Probiotic/Prebiotic Combination

Synbiotic Treatment for Osteoporosis (STARS Trial)

Roslindale, MA
N/A
Recruiting
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.

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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.Check my eligibility
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.See study design
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.
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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.
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Timeline

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.

Find a Location

Closest Location:Hebrew SeniorLife· Roslindale, MA· 1443 miles

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor
51 Previous Clinical Trials
272,298 Total Patients Enrolled
3 Trials studying Osteoporosis
5,362 Patients Enrolled for Osteoporosis
Solarea Bio, IncIndustry Sponsor
4 Previous Clinical Trials
498 Total Patients Enrolled
1 Trials studying Osteoporosis
40 Patients Enrolled for Osteoporosis
Beth Israel Deaconess Medical CenterOTHER
868 Previous Clinical Trials
12,930,689 Total Patients Enrolled
2 Trials studying Osteoporosis
410 Patients Enrolled for Osteoporosis
Tufts UniversityOTHER
270 Previous Clinical Trials
594,547 Total Patients Enrolled
7 Trials studying Osteoporosis
1,178 Patients Enrolled for Osteoporosis
MaineHealthOTHER
74 Previous Clinical Trials
43,529 Total Patients Enrolled
Shivani Sahni, PhDPrincipal InvestigatorHebrew SeniorLife
1 Previous Clinical Trials
20 Total Patients Enrolled
~147 spots leftby Apr 2028
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