Search / Trial NCT06614166

Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults

Launched by SOLAREA BIO, INC · Sep 23, 2024

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Trial Information

Current as of October 04, 2024

Recruiting

Keywords

Description

This DMA persistence food trial provides critical complimentary data to the ongoing efficacy food trials of SBD111 and SBD121 medical foods. While the SBD111 and SBD121 medical food products have been tested in multiple preclinical studies, GLP-Toxicity studies in Rats, and ongoing safety and efficacy trials, no study has yet examined how quickly these DMAs become detectable/active in human stool samples or the rate they clear from human stool following treatment cessation. The data provided by this study could inform the interpretation efficacy trial data with regard to subject adherence. ...

Gender

ALL

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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Waltham, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0