Clinical Research
Copyright ©2005 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 28, 2005; 11(20): 3105-3111
Published online May 28, 2005. doi: 10.3748/wjg.v11.i20.3105
Oral immune regulation using colitis extracted proteins for treatment of Crohn’s disease: Results of a phase I clinical trial
Eran Israeli, Eran Goldin, Oren Shibolet, Athalia Klein, Nilla Hemed, Dean Engelhardt, Elazar Rabbani, Yaron Ilan
Eran Israeli, Eran Goldin, Oren Shibolet, Athalia Klein, Nilla Hemed, Yaron Ilan, Gastroenterology and Liver Units, Department of Medicine, Hebrew University-Hadassah Medical Center, Jerusalem, Israel
Dean Engelhardt, Elazar Rabbani, Enzo Biochem, New York, NY, USA
Author contributions: All authors contributed equally to the work.
Correspondence to: Yaron Ilan, MD, Liver Unit, Department of Medicine, Hadassah University Hospital, POB 12000, Jerusalem IL-91120, Israel.
Telephone: +972-2-6777816 Fax: +972-2-6431021
Received: December 28, 2003
Revised: December 29, 2003
Accepted: February 12, 2004
Published online: May 28, 2005

AIM: To evaluate safety and possible efficacy of induction of oral immune regulation using colitis extracted proteins (CEP) in Crohn’s disease (CD) subjects.

METHODS: Ten CDs were treated orally with autologous CEP thrice weekly for 16 wk. Subjects were monitored for CDAI and IBDQ. Immune modulatory effect was assessed by T-lymphocyte FACS analysis, CEP-specific IFNγ ELISPOT assay and cytokine levels.

RESULTS: Induction of oral immune regulation significantly ameliorated disease activity. All (10/10) subjects had clinical response (CDAI ≤ 70) and 7/10 achieved clinical remission (CDAI ≤ 150). Significant increase in mean IBDQ score was noted (134±9 vs 164±12). No treatment-related adverse events were noted. High levels of CEP-specific IFNγ spot forming colonies were detected in five subjects prior to treatment and in all five, a marked decrease was observed. The CD4+/CD8+ lymphocyte ratio and peripheral NKT cell numbers increased significantly, in 7/10 and in 5/10 subjects, respectively. Significant increase in serum IL-10 and IL-4 levels was observed in 7/10 subjects during treatment period.

CONCLUSION: Immune regulation via oral administration of CEP is a safe and possibly effective treatment for subjects with moderate CD and may provide means of antigen-specific immune modulation.

Keywords: Crohn’s disease, Colitis extracted proteins