Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: A randomized, double-blind study

Table 1 Demographic and disease-related baseline characteristics (mean ± SD)

	Placebo (n = 25)	LCR35 (n = 25)
Sex, n (%)
Male	5 (20.0)	10 (40.0)
Female	20 (80.0)	15 (60.0)
Age (yr)	48.0 ± 10.8	46.1 ± 11.3
Height (cm)	163.2 ± 7.6	168.2 ± 7.6
Weight (kg)	65.5 ± 13.1	66.4 ± 14.9
BMI (kg/m²)	24.5 ± 4.0	23.4 ± 4.9
IBS severity score	247.1 ± 43.8	261.5 ± 39.4
Abdominal pain score	36.7 ± 20.6	44.6 ± 13.2
GIQLI	62.9 ± 8.6	63.9 ± 7.8
HAD score	16.5 ± 6.4	16.3 ± 6.5
IBS subgroups
IBS with predominance of constipation, n (%)	7 (28.0)	4 (16.0)
IBS severity score	270.4 ± 28.4	281.5 ± 9.9
IBS with predominance of diarrhoea	8 (32.0)	7 (28.0)
IBS severity score	259.6 ± 53.7	286.1 ± 11.2
Abdominal pain score	36.6 ± 27.2	51.4 ± 12.4
Mixed IBS, n (%)	6 (24.0)	11 (44.0)
IBS severity score	222.3 ± 36.7	245.0 ± 42.0
Unsubtyped IBS, n (%)	4 (16.0)	3 (12.0)
IBS severity score	218.5 ± 27.1	238.0 ± 63.6

NB: No statistical difference was found between the groups; BMI: Body mass index; IBS: Irritable bowel syndrome; GIQLI: Gastrointestinal quality of life index; HAD: Hospital anxiety and depression.

Table 2 Absolute and relative changes from baseline in the irritable bowel syndrome severity score referring to irritable bowel syndrome type (mean ± SD)

	Placebo (n = 25 )		LCR35 (n = 25)
	Absolute changes	Relative changes (%)	Absolute changes	Relative changes (%)
IBS with predominance of constipation	n = 7		n = 4
Post-treatment (V3-V2)	-109.4 ± 93.1	-41.0 ± 32.7	-56.8 ± 43.9	-20.5 ± 16.5
End of study (V4-V2)	-61.0 ± 96.0	-23.5 ± 35.0	-27.5 ± 31.6	-10.1 ± 11.3
IBS with predominance of diarrhoea	n = 8		n = 7
Post-treatment (V3-V2)	-1.9 ± 82.8	-3.1 ± 35.6	-105.0 ± 128.4	-36.6 ± 44.7
End of study (V4-V2)	23.9 ± 119.7	4.9 ± 46.8	-54.9 ± 151.7	-19.1 ± 53.5
Mixed IBS	n = 6		n = 11
Post-treatment (V3-V2)	-70.0 ± 91.4	-31.2 ± 38.8	-50.3 ± 99.4	-21.8 ± 39.7
End of study (V4-V2)	-68.3 ± 110.6	-30.7 ± 50.1	-53.3 ± 97.4	-20.5 ± 39.9
Unsubtyped IBS	n = 4		n = 3
Post-treatment (V3-V2)	-101.8 ± 96.2	-46.7 ± 46.7	-22.0 ± 99.9	-17.4 ± 45.9
End of study (V4-V2)	-63.8 ± 97.7	-31.3 ± 50.8	21.3 ± 140.8	4.3 ± 51.0

IBS: Irritable bowel syndrome.

Table 3 Distribution of patients according to the irritable bowel syndrome severity score classes n (%)

	Placebo (n = 25)	LCR35 (n = 25)
Baseline IBS severity score (V2)
150-300 (moderate symptoms)	25 (100.0)	25 (100.0)
Post-treatment IBS severity score (V3)
0-150 (mild symptoms)	12 (48.0)	8 (32.0)
150-300 (moderate symptoms)	8 (32.0)	13 (52.0)
> 300 (severe symptoms)	5 (20.0)	4 (16.0)
IBS severity score at the end of study (V4)
0-150 (mild symptoms)	9 (36.0)	6 (24.0)
150-300 (moderate symptoms)	8 (32.0)	13 (52.0)
> 300 (severe symptoms)	8 (32.0)	6 (24.0)

IBS: Irritable bowel syndrome.