Controlled trial comparing prednisolone with an elemental diet plus non-absorbable antibiotics in active Crohn's disease.

In a randomised clinical trial, patients with moderately active Crohn's disease received either prednisolone 0.5 mg/kg/day plus a normal diet, or an elemental diet plus oral framycetin, colistin and nystatin. Patients were assessed using the Crohn's disease activity index (CDAI), ESR, and faecal granulocyte excretion quantified by 111In-autologous leucocytes. Five patients were intolerant of the elemental diet plus antibiotics and were withdrawn from the trial within 72 hours. Sixteen patients completed 10 days treatment on each regime. Fifteen of 16 patients on elemental diet plus antibiotics and all 16 patients on prednisolone improved with marked, but statistically indistinguishable falls in CDAI, ESR, and faecal granulocyte excretion between the two groups. Thus a regime decreasing the intraluminal concentration of bacteria and complex food molecules, was associated with rapid improvement in activity of Crohn's disease. This suggests that these intraluminal factors play a role in maintaining inflammation and that their removal or alteration offers an approach to management.

RCT Entities:   Population Interventions Outcomes