IBD Trial Files Throwback: Bacteria & Metabolites Associated With Response to Fecal Microbiota Transplantation in UC and Chimeric Monoclonal Antibody cA2 to Tumor Necrosis Factor α for Crohn's
Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
Paramsothy S. et al. Gastroenterology (April 2019)
Bottom Line: This randomized controlled trial assessed the efficacy of fecal microbiota transplantation (FMT) in patients with active ulcerative colitis (UC). Conducted over 8 weeks, the double-blind study included 81 patients, who were assigned to receive either FMT from 3-7 unrelated donors or placebo enemas. The primary outcome was the induction of remission, evaluated at 8 weeks, with findings suggesting that specific bacteria and metabolic pathways are associated with remission. The study indicates that FMT may be beneficial for patients with UC and highlights the potential for microbe-based therapies.
A Short-Term Study of Chimeric Monoclonal Antibody cA2 to Tumor Necrosis Factor α for Crohn’s Disease (Crohn's Disease cA2 Study Group)
Targan S.R. et al. NEJM (October 1997)
Bottom Line: This randomized controlled trial evaluated the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor-α (TNF-α), in patients with moderate-to-severe Crohn’s disease refractory to standard therapies. Conducted as a double-blind study across multiple centers, 108 patients were randomly assigned to receive a single intravenous infusion of infliximab at varying doses or placebo. The primary outcome was clinical response at 4 weeks, defined by a significant reduction in the Crohn’s Disease Activity Index (CDAI). Results demonstrated markedly higher response and remission rates in the infliximab groups compared with placebo, with effects sustained in many patients through 12 weeks. The study established anti-TNF therapy as an effective induction treatment for Crohn’s disease and marked the beginning of the biologic era in IBD management.
IBD Trial Files Issue #IBD-2026-02
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