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 December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two medical food products, called SBD111 and SBD121, which contain a mix of beneficial bacteria (probiotics) and fibers that help these bacteria grow (prebiotics). The goal is to see how long these products stay active in the digestive system of healthy adults. Participants will take one of the products for seven days, and researchers will check their stool for changes in gut bacteria both during and after the treatment period.

To join the study, participants need to be between 18 and 64 years old, generally healthy, and willing to avoid other probiotic or prebiotic supplements during the trial. Those with certain health issues or recent surgeries may not qualify. If you participate, you can expect to follow some guidelines, report any side effects, and complete study activities over the course of about a month. This trial is currently recruiting, and anyone interested should reach out for more details.

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.

Trial Officials

Alicia E Ballok, PhD

Principal Investigator

Solarea Bio, Inc

About Solarea Bio, Inc

Solarea Bio, Inc. is a forward-thinking biopharmaceutical company dedicated to developing innovative therapies for unmet medical needs. With a focus on harnessing advanced scientific research and cutting-edge technologies, Solarea Bio aims to transform the treatment landscape for patients suffering from complex diseases. The company is committed to rigorous clinical trials and collaborations that drive the discovery and delivery of safe, effective, and accessible medical solutions. Through its dedication to excellence in research and development, Solarea Bio strives to enhance patient outcomes and improve quality of life.

Locations

Waltham, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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