Gastroenterology Center of Connecticut

Fecal microbiota, live-jslm (RBL; REBYOTA®), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing Clostridioides difficile infection (CDI) recurrence. Alternative routes of administration are of clinical interest. Evaluate the safety and efficacy of RBL administration via colonoscopy. Retrospective analysis of electronic medical records of participants administered RBL via colonoscopy under FDA enforcement discretion. The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated. TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response. Real-world safety and efficacy of RBL administered via colonoscopy were consistent with clinical trials of rectally administered RBL.

Prucalopride (1 or 2 mg once daily) is approved for treating adults with chronic idiopathic constipation (CIC). We determined the effect of age, body mass index (BMI), and renal function on the efficacy and safety of prucalopride in adults with CIC. Data were pooled from six 12-week, phase III-IV clinical studies in adults who received prucalopride (1 or 2 mg once daily) or placebo for CIC. Adults were stratified by age (<50; 50-64; ⩾65 years), BMI (underweight/healthy weight, <25 kg/m2; overweight, 25 to <30 kg/m2; obese, ⩾30 kg/m2), and renal function (normal renal function, estimated glomerular filtration rate (eGFR) ⩾90 mL/min/1.73 m2; mild renal impairment, eGFR 60 to <90 mL/min/1.73 m2; moderate renal impairment, eGFR 30 to <60 mL/min/1.73 m2). The primary efficacy endpoint was the proportion of patients with a mean of ⩾3 complete spontaneous bowel movements/week over 12 weeks. Safety data were evaluated descriptively. Of 2484 patients stratified by age (prucalopride, n = 1237; placebo, n = 1247), 1402, 708, and 374 were aged <50, 50-64, and ⩾65 years, respectively. Of 2482 patients stratified by BMI (prucalopride, n = 1237; placebo, n = 1245), 1425, 713, and 344 were underweight/healthy weight, overweight, and obese, respectively. Of 2474 patients stratified by renal function (prucalopride, n = 1233; placebo, n = 1241), 1444, 869, and 161 had normal renal function, mild renal impairment, and moderate renal impairment, respectively. More prucalopride-treated than placebo-treated patients achieved the primary efficacy endpoint. The difference was significant for all subgroups, except for the obese and moderate renal impairment subgroups. More prucalopride-treated than placebo-treated patients reported treatment-related adverse events in most subgroups. Prucalopride demonstrated efficacy in adults with CIC, irrespective of age, BMI, and renal function. No unexpected safety concerns were identified. ClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT01147926, NCT01424228, NCT01116206, NCT00483886, NCT00485940, NCT00488137.

Abstract ObjectiveThis study analyzes how authoritarian leaders use the judicial system to solve the principal–agent problem in the government hierarchy. We argue that autocrats recentralize court personnel to enhance the central government's monitoring power over local officials.MethodsOur empirical analysis takes advantage of a judicial personnel rotation reform in which the Chinese Communist Party recentralized court personnel by rotating provincial‐level court leaders in 14 out of 31 provinces.ResultsPanel data analysis shows that judicial recentralization increased adjudicated administrative lawsuits by nearly 30 percent. We also demonstrate that the enhancement in judicial responsiveness is not driven by alternative channels such as learning or the substitution between different ways of petitions.ConclusionThis study explores the dilemma faced by authoritarian leaders in balancing the need for an effective court system to address local governance issues while maintaining control, highlighting the compromise solution of recentralizing local judiciaries to partially insulate them from local interference.

Paraneoplastic syndromes represent the body's immune response to an underlying malignancy. The autoimmune response to cancer can manifest itself in multiple ways, including swelling, thickening, and changes in the hand. We report the case of a 65-year-old man who presented with hand swelling that was initially attributed to a work-related finger laceration. The patient developed edema and stiffness in the hand, which was subsequently diagnosed as Waldenström macroglobulinemia. Hand surgeons should be aware that atypical hand and wrist symptoms should raise the suspicion for the potential of a paraneoplastic syndrome and an underlying malignancy.