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Background & Aims: α4 integrins are important mediators of leukocyte migration across vascular endothelium.This pilot placebo-controlled study aimed to assess the safety and efficacy of natalizumab, a recombinant humanized monoclonal antibody to α4 integrin, in patients with mild to moderately active Crohn's disease. Methods: Thirty patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] ≥151 and ≤450) received a 3-mg/kg infusion of natalizumab (n = 18) or placebo (n = 12) by double-blind randomization.The study's primary endpoint was change in CDAI at week 2. Results: At week 2, the CDAI decreased significantly from baseline after infusion of natalizumab (mean 45 points) but not placebo (mean 11 points).Seven (39%) natalizumab-treated patients achieved remission at week 2, compared with 1 (8%) treated with placebo.In contrast, 4 (33%) of the placebo-treated patients required rescue medication by week 2, compared with 2 (11%) natalizumab-treated patients.Significant increases in circulating B and T lymphocytes were detected only after natalizumab administration.The frequency of commonly reported adverse events did not differ significantly between groups. Conclusions: A single 3-mg/kg natalizumab infusion was well tolerated by Crohn's disease patients, although the dose used may have been suboptimal.Elevated circulating lymphocyte levels after natalizumab suggest interrupted lymphocyte trafficking.Natalizumab therapy in active Crohn's disease merits further investigation. GASTROENTEROLOGY 2001;121:268-274

Background and Aims: The success rate of unguided nasojejunal feeding tube insertion is low, thus often requiring endoscopic or radiological assistance. The spiral end of the Bengmark nasojejunal tube is supposed to aid post-pyloric placement, but no comparative trial has been performed. Methods: Patients requiring nasojejunal feeding were randomised to have either Medicina (straight) or Bengmark (spiral) nasojejunal tube placed after stratification into those with normal gastric emptying or clinical evidence of delayed gastric emptying. Nasojejunal tubes were placed at the bedside in a standard fashion without radiological guidance by the same person for pre- and/or post-operative feeding. Bolus intravenous metaclopromide (10 mg) was given prior to insertion in the abnormal gastric emptying group. Abdominal radiographs were obtained at 4 and 24 h, and the primary end-point was jejunal placement at 24 h. Results: Forty-seven patients were randomised of which 17 (11 straight, 6 spiral) could not tolerate the nasojejunal tube. Of the 30 remaining patients, 16 had normal gastric emptying. In patients with normal gastric emptying, successful placement at 24 h was achieved in 78% (spiral tube), vs 14% (straight tube) (P=0.041). In the abnormal gastric emptying group, success rates were 57% and 0%, respectively (P=0.07). Conclusion: Spiral nasojejunal tubes are preferable to straight tubes for bedside unguided post-pyloric feeding in patients with normal gastric emptying.