Antimycobacterial therapy in Crohn's disease: results of a controlled, double-blind trial with a multiple antibiotic regimen

Am J Gastroenterol. 1994 Apr;89(4):513-8.


Several recent reports have suggested an association of atypical mycobacteria with Crohn's disease.

Objectives: The goal of this double-blind, placebo-controlled trial was to determine the efficacy of treatment with antimycobacterial drugs in maintaining clinical remission and in reducing active inflammatory lesions.

Methods: Forty patients (15 male) with refractory, steroid-dependent Crohn's disease were randomized to receive 2 months of tapering steroids plus either a 9-month regimen of ethambutol, clofazimine, dapsone and 1-day dose only of rifampicin (n = 22), or identical placebo.

Results: Three patients (two on active drug) were unable to discontinue steroids, and one patient on active drug was withdrawn for side effects during the first 2 months. Three of the remaining 19 patients on active drug relapsed during the study period, compared with 11 of 17 on placebo (log likelihood ratio = 4.6; p = 0.03). Another patient was withdrawn in remission at 5 months for anemia related to dapsone. Nine patients whose disease relapsed or persisted on placebo were crossed over to active drug; five achieved sustained remission, two failed, and two were withdrawn for side effects. Substantial endoscopic or radiologic healing did not occur.

Conclusion: This study suggests that the treatment regimen with rifampicin, ethambutol, clofazimine, and dapsone is effective in relief of symptoms and maintenance of remission in some Crohn's disease patients.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anti-Bacterial Agents*
  • Antitubercular Agents / therapeutic use*
  • Clofazimine / therapeutic use
  • Crohn Disease / drug therapy*
  • Crohn Disease / epidemiology
  • Crohn Disease / microbiology*
  • Dapsone / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination / therapeutic use*
  • Ethambutol / therapeutic use
  • Female
  • Humans
  • Male
  • Mycobacterium Infections, Nontuberculous / drug therapy*
  • Prospective Studies
  • Rifampin / therapeutic use
  • Time Factors


  • Anti-Bacterial Agents
  • Antitubercular Agents
  • Ethambutol
  • Dapsone
  • Clofazimine
  • Rifampin