SUMMARYBackground: Ciprofloxacin is effective in perianal Crohn's disease but after treatment discontinuation symptoms reoccur. Infliximab is effective but requires maintenance therapy. Aim: To evaluate the effect of combined ciprofloxacin and infliximab in perianal Crohn's disease. Methods: A double-blind placebo-controlled study was conducted. Patients were randomly assigned to receive 500-mg ciprofloxacin twice daily or a placebo for 12 weeks. All patients received 5-mg/kg infliximab in week 6, 8 and 12 and were followed for 18 weeks. Primary end-point was clinical response, defined as a 50% or greater reduction from baseline in the number of draining fistulae. Secondary end-points were the

Gallbladder bile contains nucleation-promoting activity that binds to concanavalin A. The activity was found in gallbladder bile from cholesterol gallstone patients but also in gallbladder bile from patients without stones and patients with pigment stones. Bile from patients with multiple cholesterol gallstones contained high concanavalin A-binding nucleation-promoting activity. The activity was much lower in bile samples from pigment stone patients, patients without stones and patients with a solitary cholesterol stone. Serum contained very little activity and no concanavalin A-binding nucleation-promoting activity could be demonstrated in gallbladder mucosa. This suggests that concanavalin A-binding nucleation promoter is produced in the liver or bile duct epithelium. The activity was fully resistant to digestion with pronase but was heat labile and could be destroyed by prolonged incubation with a mixed glycosidase preparation indicating that sugar residues are important for this activity. On a Superose 12 gel permeation column, promoting activity eluted in two major peaks at apparent molecular weights of 150 +/- 30 kD (n = 5) and less than 5 kD respectively. The mobility on the column was not influenced by pronase digestion. The factor with the higher molecular weight could be isolated further by polyacrylamide gel electrophoresis under nondenaturing conditions. On sodium dodecyl sulfate-polyacrylamide gel electrophoresis, the apparent molecular weight of the glycoprotein was 130 kD. In conclusion, gallbladder bile contains nucleation-promoting activity that binds to concanavalin A. The activity is increased in bile from patients with multiple cholesterol gallstones and could therefore play an important role in the pathogenesis of gallstone disease.

Nucleation-influencing activity was determined in T-tube bile samples derived from patients with obstructive jaundice. Since native T-tube bile samples do not nucleate, nucleation-influencing activity was determined by measuring the influence of T-tube bile on the nucleation time of model bile. In the assay, T-tube bile was mixed with model bile, and the nucleation time of this mixture was compared with the nucleation time of a model bile supplemented with the same amount of lipid as present in the bile sample. The results were expressed as ratio of the nucleation time of the mixture and the nucleation time of the control (NTm/NTc). There was a significant difference (p less than 0.01) between bile samples from patients with cholesterol gallstones and samples from patients with biliary obstruction due to other causes. More than 80% of the 33 samples from eight patients with stones were nucleation-promoting (NTm/NTc less than or equal to 0.6). Of the 40 bile samples from patients without stones, 7 were nucleation-promoting, 25 had no effect (NTm/NTc = 0.8 to 1.2) and 8 bile samples were nucleation-inhibiting (NTm/NTc greater than or equal to 1.4). There was no correlation between the lipid or protein content of a T-tube bile sample and its nucleation-influencing activity. The presence of both nucleation-promoting and nucleation-inhibiting activity in the same T-tube bile was demonstrated by chromatography on concanavalin A-Sepharose. More than 75% of the biliary protein did not bind to the column. This fraction showed nucleation-inhibiting activity.(ABSTRACT TRUNCATED AT 250 WORDS)

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