Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn’s patients

Table 3 Per-protocol analysis in the Modulen group (11 patients)

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg) (median with IQR)	63 (58.5-79.5)	65 (58.8-83.5)	65 (58-82)	77 (61-84)	0.151; 0.732; 0.183
CDAI (median with IQR)	182 (150-261)	78 (66-165)	120 (57-150)	111 (50-219)	0.0211; 0.0412; 0.113
IBDQ (median with IQR)	142 (116-170)	173.5 (138-195.8)	169 (126-201)	157 (127-199)	0.051; 0.0162; 0.0743
Lewis score (median with IQR)	337 (329-1147)	NA	322.5 (0-505.8)	NA	0.027
Total inflammatory score (median with IQR)	745 (337-1399)	NA	322.5 (0-865.8)	NA	0.027
I tertile (median with IQR)	0 (0-337)	NA	0 (0-168)	NA	0.28
II tertile (median with IQR)	143 (0-618)	NA	0 (0-35.75	NA	0.043
III tertile (median with IQR)	337 (308-618)	NA	322 (0-505)	NA	0.34
Total symptom score (median with IQR)	4.75 (1.75-5.25)	2.06 (0.75-3.31)	2.38 (0.75-4.0)	2.25 (1.0-4.63)	0.0751; 0.0912; 0.0663
Calprotectin (μg/mg) (median with IQR)	82 (22.7-118.0)	36.5 (13.5-76.9)	39.4 (29.5-91.0)	34 (14.3-110)	0.0511; 0.162; 0.593
Hemoglobin (d/dL) (median with IQR)	14.3 (13.9-15.6)	14.7 (14.0-15.6)	14.8 (13.9-15.3)	14.4 (13.9-15.5)	0.681; 0.372; 0.193
CRP (median with IQR)	3.5 (0.5-5.2)	1.0 (0.5-4.3)	3.8 (0.5-8.2)	1.4 (0.7-13.0)	0.861; 0.772; 0.333
Compliance for Modulen, portions (median with IQR)	NA	3.0 (2-3.9)	2.8 (1.5-3.7)	NA	NA

¹P baseline vs end of I month of treatment.

²P baseline vs end of II months of treatment.

³P baseline vs end of follow up of treatment.

IQR: Interquartile range; NA: Not applicable; CDAI: Crohn’s disease activity index; IBDQ: Inflammatory bowel disease questionnaire; CRP: C-reactive protein.