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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration.

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.

What data supports the effectiveness of the treatment SBD111, Bondia, SBD121, SBD121?

Research shows that probiotics, like those in the treatment, can improve bowel habits and maintain a healthy gut by supporting beneficial bacteria. Studies have also found that probiotics can help with conditions like irritable bowel syndrome and prevent antibiotic-induced diarrhea. ^{1 2 3 4 5}

Is the probiotic medical food safe for humans?

Probiotics are generally considered safe for healthy adults, but there are some risks like infections and gastrointestinal side effects, especially in vulnerable groups like infants and the elderly. Bacillus subtilis MB40, a specific probiotic strain, was found to be safe in both rats and healthy humans in studies, showing no adverse effects at tested doses. ^{4 6 7 8 9}

How is the treatment SBD111, SBD121 (Bondia) different from other treatments for digestive health?

SBD111 and SBD121 (Bondia) are unique because they use specific probiotic strains, including Saccharomyces boulardii, which are known to help restore healthy gut bacteria and improve gut health. Unlike many other treatments, these probiotics can temporarily colonize the intestine and may offer benefits like reducing diarrhea and improving symptoms of digestive disorders. ^{10 11 12 13 14}

Research Team

Alicia E Ballok, PhD

Principal Investigator

Solarea Bio, Inc

Eligibility Criteria

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

I am between 18 and 64 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2022]

2. United States 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The Unregulated Probiotic Market. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Pre- and probiotics]. [2015]

5. Canada pubmed.ncbi.nlm.nih.gov

Consumption effect of a synbiotic beverage made from soy and yacon extracts containing Bifidobacterium animalis ssp. lactis BB-12 on the intestinal polyamine concentrations in elderly individuals. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Bifidobacterium spp. as functional foods: A review of current status, challenges, and strategies. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Reappraisal of probiotics' safety in human. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Assessment of Bacillus subtilis MB40 for Use in Foods and Dietary Supplements. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Saccharomyces boulardii CNCM I-745 in different clinical conditions. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Probiotics as functional foods. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Determination of microbiological and chemical properties of probiotic boza and its consumer acceptability. [2015]

13. Poland pubmed.ncbi.nlm.nih.gov

[The significance of lactic acid bacteria in treatment and prophylaxis of digestive tract disorders]. [2006]

14. China pubmed.ncbi.nlm.nih.gov

Intestinal colonisation, microbiota and future probiotics? [2006]