ABSTRACT
BACKGROUND & AIMS: Patients recovering from mild acute pancreatitis typically receive a clear liquid diet (CLD) when ready to initiate oral nutrition. Patient discharge then depends on their successful advancement to solid food. We hypothesized that initiating oral nutrition with a low-fat solid diet (LFSD) after mild pancreatitis would be well tolerated and would result in a shorter length of hospitalization (LOH). METHODS: Patients with mild pancreatitis were randomized to a CLD or LFSD when they were ready to resume oral nutrition. Decisions about diet advancement and hospital discharge were at the discretion of the medical team, without input from study team members. Patients were monitored daily for recurrence of pain, need to stop feeding, post-refeeding LOH (primary end point), and for 28 days post-refeeding to capture re-admission rates. RESULTS: We randomized 121 patients: 66 to CLD and 55 to LFSD. The number of patients requiring cessation of feeding because of pain or nausea was similar in both groups (6% for CLD, 11% for LFSD; P = .51). The median LOH after refeeding was identical in both groups (1-day interquartile range, 1-2; P = .77). Patients in the LFSD arm consumed significantly more calories and grams of fat than those in the CLD arm during their first meal and on study day 1. There was no difference in the 28-day re-admission rates between the 2 arms. CONCLUSIONS: Initiating oral nutrition after mild acute pancreatitis with an LFSD appeared safe and provided more calories than a CLD, but did not result in a shorter LOH.
Subject(s)
Diet, Fat-Restricted/methods , Dietary Fats/therapeutic use , Nutritional Support/methods , Pancreatitis, Acute Necrotizing/diet therapy , Cholangiopancreatography, Endoscopic Retrograde , Female , Follow-Up Studies , Humans , Length of Stay , Male , Middle Aged , Pancreatitis, Acute Necrotizing/diagnosis , Prospective Studies , Severity of Illness Index , Tomography, X-Ray Computed , Treatment OutcomeABSTRACT
BACKGROUND: Intestinal inflammation associated with Crohn's disease is characterized by a type 1 helper T cell response and elevated levels of interleukin (IL)-12. We report our clinical experience with a novel oral IL-12/IL-23 inhibitor (STA 5326) for the treatment of active Crohn's disease. MATERIALS AND METHODS: We conducted an open-label, dose-escalating trial of the orally delivered small molecule immunomodulator STA 5326 in 73 patients with active Crohn's disease (Crohn's disease activity index [CDAI] 220-450, inclusive). Five cohorts of patients were treated for up to 4 weeks with 14 mg twice a day (bid), 35 mg daily (qd), 28 mg bid, 35 mg bid, or 70 mg qd. The endpoints of the study included safety and improvement in clinical activity measured by the CDAI and the Crohn's disease endoscopic index of severity. RESULTS: STA 5326 was well tolerated. Reported adverse events were similar across dose cohorts. The most common (>15%) drug-related adverse events observed were dizziness, nausea, headache, and fatigue. Clinical activity at day 28/29 was observed at qd doses of 28 mg and above for the clinical endpoints of response and remission: 70 points or greater decrease in CDAI (range 42%-82% of patients); 100 points or greater decrease in CDAI (range 38%-64% of patients), and CDAI <150 (range 15%-36%). CONCLUSIONS: Oral qd dosing of STA 5326 for 4 weeks was well tolerated in doses up to 70 mg qd in patients with active moderate to severe Crohn's disease. Clinical activity was observed at qd doses of 28 mg and above.
