Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP® DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study

Table 1 Baseline patient characteristics, n (%)

	V1 (n = 100)
Female sex	76 (76)
Age (yr), mean ± SD	47 ± 13
IBS type
Constipation-predominant	37/98 (38)
Diarrhea-predominant	31/98 (32)
Mixed	20/98 (20)
Undefined	10/98 (10)
Stool consistency (BSS score), mean ± SD	4.1 ± 1.1
Hard stool (1–2)	14/93 (15)
Normal stool (3–5)	62/93 (67)
Liquid stool (6–7)	17/93 (18)
Excessive flatulence	91/98 (93)
Defecatory disorders	26/100 (26)

V: Visit; BSS: British stool scale.

Table 2 Change in paired scores of irritable bowel syndrome symptoms after week 4 of GASTRAP^® DIRECT treatment (visit 1 to visit 3)

IBS symptoms	V1, mean ± SEM	V3, mean ± SEM	Responders, ∆ > 30%, n [% (95%CI)]	Paired decrease, mean ± SE (%)
Abdominal pain (0–10)	5.8 ± 2.4	2.9 ± 2.0c	64/96 [67 (57; 75)]	-2.9 ± 0.3 (50)
Bloating (0–10)	8.0 ± 1.7	4.7 ± 2.9c	58/96 [60 (50; 70)]	-3.2 ± 0.3 (40)
Abdominal distension (0–10)	7.2 ± 2.1	4.4 ± 3.1c	51/96 [53 (43; 63)]	-2.8 ± 0.4 (39)
Impact of global symptoms on daily life	7.1 ± 2.0	4.6 ± 2.9c	51/94 [54 (44; 64)]	-2.5 ± 0.3 (35)

^cP < 0.001.

95%CI: Confidence interval of the responder rate (Wilson method); IBS: Irritable bowel syndrome; V: Visit.

Table 3 Symptom relief at weeks 2 and 4 of GASTRAP^® DIRECT treatment

Symptom relief	W2 (%)	W4 (%)
Abdominal pain
Unchanged	42	34
Relief (very much, considerable)	58 (53, 5)	66 (48, 18)
Bloating
Unchanged	48	33
Relief (very much, considerable)	52 (45, 7)	67 (49, 18)
Abdominal distension
Unchanged	55	43
Relief (very much, considerable)	45 (33, 12)	57 (40, 17)
Impact of global symptoms on daily life
Unchanged	37	23
Relief (very much, considerable)	63 (42, 21)	77 (53, 24)
Flatulence
Unchanged	46	44
Relief (very much, considerable)	54 (44, 10)	56 (41, 15)

W: Week.

Table 4 Symptom relief at week 4 of GASTRAP^® DIRECT treatment in patients with IBS having prevalent constipation, diarrhea, and mixed irritable bowel syndrome

Symptom relief at W4	IBS-C (%)	IBS-D (%)	IBS-M (%)
Abdominal pain
Unchanged	42	27	34
Relief (very much, considerable)	58 (50, 8)	73 (46, 27)	66 (48, 18)
Bloating
Unchanged	42	32	31
Relief (very much, considerable)	58 (46, 12)	68 (41, 27)	69 (53, 16)
Abdominal distension
Unchanged	46	50	39
Relief (very much, considerable)	54 (39, 15)	50 (36, 14)	61 (39, 21)

W: Weeks; IBS: Irritable bowel syndrome; IBS-C: IBS patients with prevalent constipation; IBS-D: IBS patients with prevalent diarrhea; IBS-M: IBS patients with mixed symptoms.

Table 5 Relief of altered stool pattern at weeks 2 and 4 of GASTRAP^® DIRECT treatment

Symptom relief (% vs W0)	W2 (%)	W4 (%)
Constipation
Unchanged	58	54
Relief (very much, considerable)	42 (27, 15)	46 (37, 9)
Diarrhea
Unchanged	44	42
Relief (very much, considerable)	46 (42, 14)	58 (39, 19)
Defecatory disorders
Unchanged	56	58
Relief (very much, considerable)	44 (36, 8)	42 (31, 11)

W: Week.