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Probiotic Medical Food

Probiotic Medical Food for Healthy Adults

N/A

Recruiting

Led By Alicia E Ballok, PhD

Research Sponsored by Solarea Bio, Inc

Eligibility Criteria Checklist

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

Must have

Age 18-64 years

Be between 18 and 65 years old

Must not have

Currently taking probiotic or prebiotic supplements or have taken them in the past 30 days

Major surgery on the intestines or endoscopy within last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test a new medical food product made of probiotics and prebiotics on healthy volunteers. They will take either SBD111 or SBD121 for seven days, and researchers will measure

Who is the study for?

This trial is for healthy adults who are interested in how certain medical foods, specifically probiotics and prebiotics, affect their body. Participants should not have any gastrointestinal blockages or conditions like rheumatoid arthritis or osteoporosis that could influence the study's results.

What is being tested?

The trial is testing two medical food products: SBD111 and SBD121. Both contain a mix of probiotics and prebiotics. The study will track how these products change the number of microbes in participants' feces over seven days of use and then for four weeks after.

What are the potential side effects?

Since this trial involves probiotic medical foods, side effects may include digestive discomfort such as gas, bloating, or changes in bowel habits as the body adjusts to increased microbial activity.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 64 years old.

Exclusion Criteria

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

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I am currently taking or have recently taken probiotic or prebiotic supplements.

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I haven't had major intestinal surgery or an endoscopy in the last 3 months.

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My vital signs or health checks from the questionnaire show significant issues.

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I do not have an active bowel leak, stomach issues, or a history of serious digestive diseases.

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I have had Hepatitis B or C, cirrhosis, or chronic liver disease.

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I have had heart valve issues, endocarditis, or heart surgery.

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I have been diagnosed with Celiac disease.

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I have an autoimmune disease and am on immunosuppressants.

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I do not have active tuberculosis.

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I am not pregnant, planning to become pregnant soon, or breastfeeding.

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I have fewer than one bowel movement every 36 hours.

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I am immunosuppressed, possibly due to HIV, organ transplant, or taking immunosuppressive drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Persistence of SBD111 and SBD121 microbes in fecal samples

Secondary study objectives

Microbial Community Structure Changes

Other study objectives

Microbe Viability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Synbiotic Medical Food SBD121Experimental Treatment1 Intervention

Probiotic comprised of three lactic acid bacteria and one bacillus

Group II: Synbiotic Medical Food SBD111Experimental Treatment1 Intervention

Probiotic comprised of three lactic acid bacteria and one yeast

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Solarea Bio, IncLead Sponsor

4 Previous Clinical Trials

678 Total Patients Enrolled

1 Trials studying Osteoporosis

220 Patients Enrolled for Osteoporosis

Alicia E Ballok, PhDPrincipal InvestigatorSolarea Bio, Inc

~7 spots leftby Dec 2024

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