2018
DOI: 10.14309/00000434-201810001-02738
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Quality of Life Increased After Treatment for Participants in a Phase 2B Randomized, Double-Blinded, Placebo-Controlled Clinical Trial of RBX2660 for Preventing Recurrent Clostridium difficile Infections

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“…From an analysis of Medicare Fee-for-service beneficiaries, within a 12-month period after an initial CDI episode, approximately 15–20% of the cohort had newly diagnosed psychiatric conditions (anxiety, depression, delirium) ( 7 ). After receiving a microbiota-based LBP for CDI treatment in a phase 2 trial setting, participants exhibited statistically significant and clinically meaningful improvements in the mental component score of the SF-36 assessment of quality of life (QoL) ( 74 ). From a phase 3 randomized, controlled trial, using a the CDiff32, a CDI-specific measure of QoL, patients receiving an LBP reported significant improvements in mental health-related QoL as early as week 1, which continued throughout the 8-week blinded study period ( 75 ).…”
Section: Approaches To Restoring the Gut Microbiotamentioning
confidence: 99%
“…From an analysis of Medicare Fee-for-service beneficiaries, within a 12-month period after an initial CDI episode, approximately 15–20% of the cohort had newly diagnosed psychiatric conditions (anxiety, depression, delirium) ( 7 ). After receiving a microbiota-based LBP for CDI treatment in a phase 2 trial setting, participants exhibited statistically significant and clinically meaningful improvements in the mental component score of the SF-36 assessment of quality of life (QoL) ( 74 ). From a phase 3 randomized, controlled trial, using a the CDiff32, a CDI-specific measure of QoL, patients receiving an LBP reported significant improvements in mental health-related QoL as early as week 1, which continued throughout the 8-week blinded study period ( 75 ).…”
Section: Approaches To Restoring the Gut Microbiotamentioning
confidence: 99%