Inflammatory bowel disease (IBD) is a chronic inflammatory disorder, which includes Crohn’s disease (CD) and ulcerative colitis (UC). The aim of IBD therapy is to induce sustained remission, a state of long lasting quiescent disease. Several drugs exist to induce and maintain remission. For patients with CD remission is induced with corticosteroids, and maintenance of remission is only achieved with immunosuppressive drugs, mainly thiopurines or biologics such as anti-TNF alpha inhibitors.
Recent work indicates that administration of low dose Naltrexone (LDN) may also result in maintained remissionin patients with mild to moderate CD.
This study will be a 12-week, multicenter, randomized, placebo-controlled study, in 112 patients with mild to moderate active CD failing conventional treatment or having side effects to conventional treatment.
The study is designed to assess the efficacy of LDN for the induction of endoscopic remission in mild to moderate CD.