Probiotic Medical Food for Healthy Adults

Overseen By Alicia E Ballok, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Solarea Bio, Inc

Must not be taking: Probiotics, Prebiotics, Antibiotics, Immunosuppressants

Disqualifiers: Smoker, Drug/alcohol abuse, GI disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a medical food with probiotics and prebiotics, called SBD111 or SBD121, affects the gut in healthy adults. Participants will take one of these products for a week while researchers monitor changes in gut bacteria. Individuals who are generally healthy, not currently using probiotics, and have no recent history of major intestinal surgeries or antibiotic use may qualify for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on gut health.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take probiotic or prebiotic supplements during the study. If you are on antibiotics or have taken them recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both SBD111 and SBD121 are generally safe for people. Research indicates that these probiotic blends are well-tolerated, with only mild side effects reported. Testing revealed that SBD111 caused mild stomach issues in a few cases, suggesting safety for most individuals. Similarly, studies found SBD121 safe when rats took it for 28 days, and human trials reported very few negative effects. These findings suggest that both SBD111 and SBD121 are safe options for those considering joining the clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Synbiotic Medical Foods SBD111 and SBD121 because they offer a novel approach to promoting gut health in adults. Unlike traditional probiotics, which often contain only bacteria, SBD111 incorporates a unique blend of three lactic acid bacteria and one yeast, while SBD121 combines three lactic acid bacteria with a bacillus. These combinations are designed to enhance digestive health by providing a diverse range of beneficial microorganisms, potentially offering more comprehensive support for the gut microbiome compared to standard single-strain probiotics.

What evidence suggests that this trial's treatments could be effective?

In this trial, participants will receive either SBD111 or SBD121. Research has shown that SBD111 has been tested in several studies, primarily examining its impact on bone health. In some women with osteopenia and a high body mass index (BMI), SBD111 reduced bone loss, suggesting it might help maintain bone health in certain groups.

For SBD121, studies have mostly focused on its use for rheumatoid arthritis, a condition that causes joint inflammation. Early research indicates it is safe and well-tolerated, with the active ingredients present in most participants' systems. Both SBD111 and SBD121 have shown promise in terms of safety and potential benefits based on their ingredients. ^{5 6 7 8 9}

Who Is on the Research Team?

Alicia E Ballok, PhD

Principal Investigator

Solarea Bio, Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to follow the study rules and report my experience.

Provide written informed consent

Body Mass Index between 18.5 and 35 kg/m2

Exclusion Criteria

I understand the study and can follow its requirements.

I have fewer than one bowel movement every 36 hours.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the medical food product SBD111 or SBD121 for 7 days

1 week

Daily administration

Follow-up

Participants are monitored for microbial abundance in feces for 4 weeks following administration

4 weeks

Weekly sample collection

What Are the Treatments Tested in This Trial?

Interventions

• SBD111
• SBD121

Trial Overview 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.

How Is the Trial Designed?

Group I: Synbiotic Medical Food SBD121 Experimental Treatment 1 Intervention

Probiotic comprised of three lactic acid bacteria and one bacillus

Group II: Synbiotic Medical Food SBD111 Experimental Treatment 1 Intervention

Probiotic comprised of three lactic acid bacteria and one yeast

Who Is Running the Clinical Trial?

Solarea Bio, Inc

Lead Sponsor

Trials

5

Recruited

720+

Published Research Related to This Trial

In a randomized, double-blind, placebo-controlled study involving healthy adults, daily consumption of the probiotic combination SYNBIO® significantly improved bowel habits compared to the control group.

The study also confirmed that the probiotic strains persisted in the gastrointestinal tract, indicating their potential for long-term benefits in bowel health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic-enriched foods and dietary supplement containing SYNBIO positively affects bowel habits in healthy adults: an assessment using standard statistical analysis and Support Vector Machines. Silvi, S., Verdenelli, MC., Cecchini, C., et al.[2022]

The study found that Bifidobacterium animalis subsp lactis (BB-12) supplemented yogurt is safe and well tolerated by healthy adults taking antibiotics, with no significant differences in adverse events compared to control yogurt.

BB-12 supplementation led to modestly higher levels of the probiotic in feces and some changes in immune cell gene expression, suggesting potential immunomodulatory effects that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study. Merenstein, DJ., Tan, TP., Molokin, A., et al.[2018]

Probiotics and prebiotics have been traditionally consumed for their health benefits, particularly for gut health, and there is growing scientific interest in the gut microbiota's role in health and disease.

While some human diseases, such as diarrheal illnesses and inflammatory bowel diseases, may benefit from probiotics, there is still a lack of extensive clinical evidence supporting their use, especially for prebiotics, which have not been widely tested in large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. Quigley, EM.[2022]

Saccharomyces boulardii CNCM I-745 is an effective probiotic for treating acute gastroenteritis, shown to safely reduce diarrhea duration and hospitalization by about one day, making it a recommended option for children by leading pediatric societies.

It is also beneficial in preventing antibiotic-associated diarrhea, improving treatment compliance and reducing side effects during Helicobacter pylori eradication, although there is insufficient evidence for its long-term use in irritable bowel syndrome and inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saccharomyces boulardii CNCM I-745 in different clinical conditions. Dinleyici, EC., Kara, A., Ozen, M., et al.[2018]

Pre- and probiotics have shown promising effects on gut health by maintaining a healthy gut microflora and influencing metabolic and immune mechanisms, but scientific proof of their benefits in humans is still lacking.

Certain clinical conditions, such as ulcerative colitis and antibiotic-induced diarrhea, have demonstrated therapeutic benefits from pre- and probiotics, suggesting potential for broader applications in gut health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pre- and probiotics]. Meier, R., Lochs, H.[2015]

Probiotics, while generally considered safe, can pose significant risks including systemic infections, gastrointestinal issues, and immune system stimulation, particularly in vulnerable populations such as infants, the elderly, and immunocompromised individuals.

The review highlights the need for careful evaluation of the risk-benefit ratio of probiotics before recommending their use, given the variety of adverse effects reported across different studies and case reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reappraisal of probiotics' safety in human. Sotoudegan, F., Daniali, M., Hassani, S., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40815418/

A randomized, double-blind, placebo-controlled clinical ... SBD111 did not significantly reduce bone loss for the full cohort, but showed reduced bone loss in women with osteopenia and BMI ≥ 30.

2. medrxiv.org medrxiv.org/content/10.1101/2025.05.20.25325893v1

A randomized, double-blind, placebo-controlled clinical ... This 12-month study in 286 early postmenopausal women evaluated the efficacy and safety of SBD111, a synbiotic medical food, in reducing bone loss.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06389539

Study Details | NCT06389539 | Synbiotic to Attenuate ... This study tests a synbiotic's effect on bone mineral density in older women, using SBD111 medical food, with lumbar spine BMD as the primary outcome.

4. marcusinstituteforaging.org marcusinstituteforaging.org/news/3m-grant-supports-study-probioticprebiotic-synbiotic-medical-food-bone-health-older-women

$3M Grant Supports Study of Probiotic/Prebiotic (Synbiotic) ... The study will support an 18-month clinical trial of a synbiotic medical food in 220 older women to test whether it maintains lumbar spine bone mineral density ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140515/

A randomized, double-blind, placebo-controlled clinical ... This 12-month study in 286 early postmenopausal women evaluated the efficacy and safety of SBD111, a synbiotic medical food, in reducing bone loss.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0278691522005270

Food safety assessment and toxicity study of the synbiotic ... SBD111 is a consortium of probiotic microbes designed to promote bone health. · SBD111 was evaluated in rats at 2.0 x 1010, 9.8 x 1010, or 2.0 x 1011 CFU/kg-bw.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35948142/

Food safety assessment and toxicity study of the synbiotic ... A 28-day repeated administration study was performed to evaluate the oral toxicity of SBD111 in female rats (age/weight at study start: 5-7 weeks/120-180 g)

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05206864

Food Trial to Evaluate the Safety and Tolerability of ... The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults.

9. cdn.nutrition.org cdn.nutrition.org/article/S2475-2991(23)13066-6/fulltext

Safety and Tolerability of SBD111 an Optimized Probiotic ... The relatively low frequency and mild severity of GI symptoms and AEs suggests that SBD111 at the level tested is safe for human consumption and that SBD111 ...