Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults

Other illness

• • Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days. If participant is willing to stop taking probiotic or prebiotic supplement for 30-days, they can be re-screened for eligibility and enrollment after consent.
  • Unwilling to avoid probiotics/prebiotics supplements for the duration of the study.
  • Known or suspected allergies to probiotics, maltodextrin, or berries.
  • Received oral or parenteral antibiotics within 30 days of enrollment or prescribed antibiotics on the day of enrollment.
  • Major surgery on the intestines or endoscopy within last 3 months.
  • History of drug and/or alcohol abuse at the time of enrollment.
  • Presence of any of the following based on participant reported health history:
  • Clinically significant systems abnormalities based on screening questionnaire.
  • Indwelling catheter or feeding tube.
  • Febrile illness (oral temperature \>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first administration of study article).
  • Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease.
  • History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.
  • Underlying structural heart disease or previous history of endocarditis or valve replacement.
  • Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy.
  • History of Celiac disease.
  • History of cancer.
  • Excluding non-melanoma skin cancers or cancer more than 10 years ago.
  • History of autoimmune disease and taking any immunosuppressant drugs.
  • Active tuberculosis.
  • Pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first administration of DMA.
  • Participants may be excluded if, in the investigator's opinion, there is evidence of cognitive impairment or dementia which is sufficient to interfere with informed consent or adherence to the study protocol. Four questions will be asked during the informed consent process to confirm participant's understanding and ability to comply. (See section 8.3)
  • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.
  • Bowel movement frequency less than one per 36-hour period.
  • If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.

• Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
• Age 35 years or older.
• Be in general good health as determined by a screening evaluation within 30 days of the first administration of SBD111 medical foods.
• Willing to comply with protocol and report on compliance and side effects during study period.
• Body Mass Index between 18.5 and 40kg/m2.