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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 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

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
~0 spots leftby Dec 2024
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