Oral immune regulation using colitis extracted proteins for treatment of Crohn's disease: results of a phase I clinical trial.
OBJECTIVE
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 IFNgamma ELISPOT assay and cytokine levels.


RESULTS
Induction of oral immune regulation significantly ameliorated disease activity. All (10/10) subjects had clinical response (CDAI < or = 70) and 7/10 achieved clinical remission (CDAI < or = 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 IFNgamma 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.


CONCLUSIONS
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.
Israeli
Eran
E
Gastroenterology Unit, Department of Medicine, Hebrew University-Hadassah Medical Center, Jerusalem, Israel.
Goldin
Eran
E
Shibolet
Oren
O
Klein
Athalia
A
Hemed
Nilla
N
Engelhardt
Dean
D
Rabbani
Elazar
E
Ilan
Yaron
Y
D000284:Administration, Oral; D000328:Adult; D003106:Colon / Q000166:cytology; D003424:Crohn Disease / Q000276:immunology* / Q000628:therapy*; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000166:cytology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011506:Proteins / Q000008:administration & dosage*
D011506:Proteins