Before morning dose Sample Clauses

Before morning dose c: 0, 1, 2, 4, 8, 12, 24, 48 hours post dose. d: Samples voided over each 24 hour period to be pooled for analysis 125 Although feedback from the Translation Award committee is that assessment of faecal samples for gut flora composition should not be included, Summit recommends that this remain a part of the Phase 1 trial for the following reasons: • The Phase 1 is the only opportunity to assess the effects of SMT19969 on a healthy and complete gut microbiota since the gut flora in CDI patients is significantly damaged. • Should any deleterious effects against gut flora be observed during the MAD phase at higher doses then a preliminary dose response relationship between GI concentrations and gut flora inhibition will be established. This will be valuable data in dose selection for Phase 2. • The cost of this analysis is minimal as all faecal samples voided during the course of the MAD phase are to be collected anyway and low cost, simple culture methods to analyse gut flora are to be used rather than the 16S RNA sequencing methods to be used in the proposed patient trial. • Data from the human gut model (detailed in SDDi Milestone 1 report) showed that total Clostridia were reduced during SMT19969 treatment. As Clostridia are often resident in the human GI tract, observation of a similar reduction would give a surrogate endpoint for an antibiotic effect in humans.
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