Current Therapeutic Options for Gut Microbiome Restoration Are Limited Phase 2


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Get the full story of the microbiome

  1. Importance of Microbial Diversity
  2. Dysbiosis and Recurrent C. difficile Infection
  3. Currently Approved Treatment Options
  4. Historic Microbiome Restoration Approaches
  5. Patient and Healthcare Burdens

Historic approaches to microbiome restoration have limitations

The aim of microbiome restoration is to repopulate
a diverse gut microbiota to treat disease.

For recurrent C. difficile infection (rCDI), one approach is fecal microbiota transplantation (FMT). FMT has been shown to be efficacious in treating rCDI and reestablishing gut biodiversity.1 However…

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  • Resource intensive: may involve bowel preparation, anesthesia, NG tubes, and risk of perforation2
  • FDA has issued multiple safety alerts regarding the potential risk of serious or life-threatening infections following FMT3
    -Not FDA-approved: no regulated testing criteria for safety or standardized manufacturing4,5
  • Digestive environment may compromise FMT microorganisms delivered orally6,7
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Clinical studies
Most data are from retrospective case series or systemic reviews with considerable variability.8

Treatment success in 13 clinical trialsa of single-dose FMT8

67.7% Randomized controlled trials
82.7% Open-label studies
  • This inconsistency is due to considerable heterogeneity among randomized controlled trials, with marked differences in study structure, control groups, fecal transplant materials, and outcome assessments9,10
  • Patients enrolled in clinical trials may not be a true reflection of patients seen in the real world. Strict inclusion and exclusion criteria in randomized controlled trials lead to inclusion of a small portion of patients from daily clinical practice, limiting generalizability of results to patients seen in clinical practice8

Probiotics do not restore the microbiome nor address dysbiosis

  • Designed to help maintain a healthy gut microbiome11
  • Clinical guidelines recommend against probiotics for the prevention of rCDI12
  • May hinder normal colon recolonization following antibiotic treatment13

A safe, regulated, and reliable option is vitally needed to reduce
the burdens of CDI and recurrence.

FDA, US Food and Drug Administration; NG, nasogastric.