Investigator-Initiated Trials

OpenBiome supports research programs at leading medical research institutions around the world. Through our Investigator-Initiated Trials program, OpenBiome offers clinical investigators a range of services to enable FMT trials.

The Investigator-Initiated Trials Program is overseen by our Scientific & Safety Review Board and supported by our Clinical Advisory Board, whose members are leading clinicians and scientists from gastroenterology, infectious disease, internal medicine, and microbiology.

OpenBiome Provides:

  • Access to fecal microbiota preparations and placebo preparations for FMT
  • Access to collection kits and sequencing services (16s, MDRO, Shotgun Metagenomics)
  • Clinical safety review and scientific guidance on initial proposal study design 
  • Limited regulatory support
  • Optional add-on services:
    • Customized FMT treatments via donor selection
    • Consultation on protocol design, analysis plan, manuscript consultation

Investigator Provides:

  • Full study oversight and management
  • Initial and ongoing approval from FDA and IRB (and/or relevant international regulatory agencies)
  • Responsibility for safety and efficacy
  • Timely safety reporting to OpenBiome and applicable regulatory agencies
  • Full project funding

Occasionally, OpenBiome may reach out to a Principal Investigator who has proposed a study that is of deep relevance to our mission to explore the opportunity for a deeper collaboration. OpenBiome may offer a combination of ongoing consultation, protocol development, deeper regulatory assistance, subsidized FMT preparations, sequencing data analysis, and funding in exchange for deeper engagement on the design and execution of the trial and greater access to resulting data.

Reference: 

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