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

Table 5 Per-protocol analysis in the budesonide group (7 patients)

	Baseline	End of I month of treatment	End of II months of treatment	Follow-up	P value
Weight (kg) (median with IQR)	85.2 (66.4-90.25)	82.75 (66.3-91.5)	82.5 (66.25-91.25)	83.5 (66.3-91.3)	0.461; 0.342; 0.213
CDAI (median with IQR)	216 (151-267)	89 (39.8-89.0)	180 (78.5-227.5)	69 (28-171)	0.0071; 0.502; 0.0443
IBDQ (median with IQR)	159 (133-171)	179 (167-204)	152 (149-183)	169 (152-195)	0.191; 0.22; 0.183
Lewis score (median with IQR)	412 (337-1690)	NA	337 (0-1690)	NA	0.14
Total inflammatory score (median with IQR)	637 (472-1124)	NA	674 (0-809)	NA	0.23
I tertile (median with IQR)	143 (0-450)	NA	135 (0-337)	NA	0.36
II tertile (median with IQR)	0 (0-337)	NA	0 (0-337)	NA	0.66
III tertile (median with IQR)	337 (143-412)	NA	337 (0-412)	NA	0.29
Total symptom score (median with IQR)	3.75 (1.68-5.25)	2.43 (0.18-3.63)	3.25 (0.94-5.50)	2.87 (2.0-5.25)	0.481; 0.52; 0.43
Calprotectin score (μg/mg) (median with IQR)	336 (47.35-671.0)	17 (10.75-113.85)	14 (8.7-46.65)	15 (13-61)	0.0541; 0.052; 0.0513
Hemoglobin, d/dL (median with IQR)	13.7 (12.1-14.45)	14.6 (12.2-15.65)	13.8 (11.85-15.15)	14.4 (12.3-15.4)	0.0371; 0.182; 0.0143
CRP (median with IQR)	3.2 (1.0-13.6)	1.0 (0.5-2.9)	1.0 (0.5-3)	1.0 (0.5-2)	0.0171; 0.0172; 0.0383

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.