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Probiotic/Prebiotic Combination

SBD111 medical food 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over 18 months

Awards & highlights

STARS Trial 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.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.

STARS Trial 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.

STARS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lumbar spine BMD (g/cm2)

Secondary outcome measures

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

STARS 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor

46 Previous Clinical Trials

270,549 Total Patients Enrolled

2 Trials studying Osteoporosis

3,809 Patients Enrolled for Osteoporosis

Solarea Bio, IncIndustry Sponsor

3 Previous Clinical Trials

472 Total Patients Enrolled

Beth Israel Deaconess Medical CenterOTHER

838 Previous Clinical Trials

13,010,272 Total Patients Enrolled

2 Trials studying Osteoporosis

410 Patients Enrolled for Osteoporosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to enroll in this ongoing investigation?

"Per the data on clinicaltrials.gov, recruitment for this particular trial is not ongoing. The trial's initial posting was on May 1st, 2024, and its latest update occurred on April 24th, 2024. Although this study is not actively enrolling participants, there are currently 677 alternative studies that are accepting patient enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Synbiotic to Attenuate Resorption of the Skeleton

2024. "Synbiotic to Attenuate Resorption of the Skeleton". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06389539.

All > Osteoporosis