Safety and Tolerability of CP101, a full spectrum, oral microbiome therapeutic for the prevention of recurrent C. difficile infection: A Phase 2 Randomized Controlled Trial.
Allegretti J, Kelly C, Louie T, Fischer M, Hota S, Misra B, Van Hise N, Yen E, Bullock J, Silverman M, Davis I, McGill S, Pardi D, Orenstein R, Grinspan A, El-Nachef N, Feuerstadt P, Borody T, Khanna S, Budree S, Kassam Z. Safety and Tolerability of CP101, a full spectrum, oral microbiome therapeutic for the prevention of recurrent C. difficile infection: A Phase 2 Randomized Controlled Trial. Gastroenterology 2024 PMID: 39366468, DOI: 10.1053/j.gastro.2024.09.030.Peer-Reviewed Original ResearchCDI recurrenceRecurrent Clostridioides difficile infectionClostridioides difficile infectionGroup compared to placeboStandard-of-careWeek 8Preventing recurrent Clostridioides difficile infectionReduce recurrent Clostridioides difficile infectionSafety profile similar to placeboRecurrent C. difficile infectionIncidence of adverse eventsPlacebo-controlled trialPrevention of recurrent C. difficile infectionPhase 2 randomized controlled trialMicrobiome therapeuticsToxin EIADouble-blindEfficacy endpointPCR-based testsDiagnostic modalitiesOral doseDifficile infectionProportion of participantsAdverse eventsPlaceboEfficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies
Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash B. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Therapeutic Advances In Gastroenterology 2024, 17: 17562848241299731. PMID: 39664231, PMCID: PMC11632959, DOI: 10.1177/17562848241299731.Peer-Reviewed Original ResearchChronic idiopathic constipationBody mass indexSafety of prucalopridePlacebo-treated patientsRenal functionRenal impairmentEfficacy endpointIdiopathic constipationMass indexClinical studiesTreatment-related adverse eventsPlacebo-controlled clinical studyRenal impairment subgroupsMild renal impairmentModerate renal impairmentNormal renal functionProportion of patientsPost hoc analysisUnderweight/healthy weightAdverse eventsPrucaloprideIII and IVSafety dataPatientsTreating adults