Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT06614166
Eligibility Criteria:
Inclusion Criteria:
1. Provide written informed consent.
2. Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
3. Age 18-64 years.
4. Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or SBD121.
5. Willing to comply with protocol and report on compliance and side effects during study period.
6. Body Mass Index between 18.5 and 35 kg/m2.
Exclusion Criteria:
1. Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days.
2. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study.
3. Known or suspected allergies to probiotics, maltodextrin, or berries.
4. Received oral or parenteral antibiotics within 3 months of enrollment or prescribed antibiotics on the day of enrollment.
5. Major surgery on the intestines or endoscopy within last 3 months.
6. Current smoker.
7. History of drug and/or alcohol abuse at the time of enrollment.
8. Presence of any of the following:
9. Abnormal vital signs or clinically significant systems abnormalities based on screening questionnaire.
10. Indwelling catheter or implanted hardware/prosthetic device or feeding tube.
a. Excluding joint replacements
11. Febrile illness (oral temperature \>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first dose of study article).
12. 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.
13. History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.
14. Underlying structural heart disease or previous history of endocarditis or valve replacement.
15. Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy.
16. History of Celiac disease.
17. History of cancer.
18. Excluding non-melanoma skin cancers or cancer more than 10 years ago.
19. History of autoimmune disease and taking any immunosuppressant drugs.
20. Active TB.
21. Women only - pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first dose of DMA.
22. 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.
23. 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.
24. Bowel movement frequency less than one per 36-hour period.
25. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT06614166
Study Brief:
Protocol Section:
NCT06614166