Effects of a Probiotic on Aspects of Mental Wellness

Exclusion Criteria

• •1. Daily consumption of prebiotic, postbiotic, or probiotic supplements as well as foods/beverages fortified to contain live probiotics (e.g., kombucha) within 2 weeks of screening.
• •2. Clinically diagnosed neurologic or psychiatric disorders (e.g., bipolar disorder, clinical depression, post-partum depression) currently requiring medication, such as antipsychotics, anticonvulsants, and antiparkinsonian agents as well as medications for bipolar disorder.
• •3. Current use of prescription stimulant medications \[e.g., amphetamines/dextroamphetamine (Adderall), methylphenidate (Ritalin, Concerta), methamphetamine (Desoxyn), dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse)\].
• •4. Current use of antibiotics.
• •5. Clinically diagnosed GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease).
• •6. Use of cannabis, marijuana or cannabinoid products, including those that are consumed, orally inhaled, smoked, applied topically, etc. within 6 months of screening.
• •7. Contraindication or allergy/sensitivity to any components in the study product or allergens present in the facility used to manufacture or pack the study product (Appendix 7).
• •8. Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
• •9. Exposure to any non-registered drug product within 4 weeks of screening.
• •10. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
• •11. Recent history of (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• •12. Has a condition the Clinical Investigator believes would interfere with the subject's ability to provide informed consent, comply with the study protocol, confound the interpretation of the study results, or put the subject at undue risk.