Efficacy and dose response of Lactiplantibacillus plantarum in diarrhea-predominant irritable bowel syndrome

Table 1 Baseline demographics and clinical characteristics of the intention-to-treat population, n (%)

	Placebo 1B (n = 104)	L. plantarum 1B (n = 104)	L. plantarum 10B (n = 99)	P value
	mean (SD) or n (%)	mean (SD) or n (%)	mean (SD) or n (%)
Age (yr)	39.50 (13.26)	38.66 (11.25)	40.46 (11.15)	0.56191
Female allocation	46 (44.23)	50 (48.08)	44 (44.44)	0.82322
Height (m)	1.60 (0.07)	1.59 (0.08)	1.61 (0.07)	0.17751
Weight (kg)	63.57 (9.10)	63.09 (9.01)	63.25 (8.50)	0.92561
BMI (kg/m2)	24.83 (3.15)	25.01 (3.31)	24.46 (2.92)	0.45061
Systolic BP (mmHG)	119.68 (8.27)	119.76 (8.68)	118.88 (8.79)	0.72231
Diastolic BP (mmHG)	79.29 (5.06)	79.21 (6.30)	78.75 (4.62)	0.74291
Fasting glucose (mmol/L)	5.16 (0.66)	5.01 (0.65)	5.13 (0.62)	0.19611
IBS-SSS aggregate score	308.70 (70.91)	315.20 (62.79)	302.85 (61.06)	0.40901
APS-NRS score	7.14 (0.69)	7.14 (0.77)	7.17 (0.86)	0.96481
IBS-QoL aggregate score	36.19 (17.97)	37.83 (17.25)	37.54 (17.02)	0.77871
PSS score	22.06 (4.29)	22.42 (4.12)	21.93 (4.31)	0.69121

¹Between group comparison; one-way ANOVA.

²Between group comparison; Pearson chi-square test.

BMI: Body mass index; BP: Blood pressure; IBS-SSS: Irritable bowel syndrome-severity scoring system; APS-NRS: Abdominal pain severity-numeric rating scale; IBS-QoL: Irritable bowel syndrome-quality of life; PSS: Perceived stress scale; L. plantarum: Lactiplantibacillus plantarum.

Table 2 Irritable bowel syndrome symptom severity total and domain-specific scores over the intervention period

	Placebo (n = 104)	L. plantarum 1B (n = 104)		L. plantarum 10B (n = 99)
	mean (SD)	mean (SD)	P vs Placebo1	mean (SD)	P vs Placebo1	P vs 1B dose2
IBS-SSS total score
Day 0	308.70 (70.91)	315.95 (62.07)		302.85 (61.06)
AbsΔ (Day 28)	-35.68 (60.81)	-66.37 (72.27)	0.0098	-85.80 (89.53)	< 0.0001	0.0956
AbsΔ (Day 56)	-58.82 (74.75)	-128.45 (83.30)	< 0.0001	-156.77 (99.06)	< 0.0001	0.0298
Abdominal pain severity
Day 0	67.05 (17.11)	68.80 (13.40)		67.07 (13.77)
AbsΔ (Day 28)	-9.24 (19.67)	-15.45 (18.36)	0.0830	-20.76 (22.76)	< 0.0001	0.0736
AbsΔ (Day 56)	-14.38 (21.18)	-28.91 (20.36)	< 0.0001	-36.52 (24.39)	< 0.0001	0.0176
Abdominal pain duration
Day 0	41.11 (14.13)	42.60 (14.55)		39.37 (13.75)
AbsΔ (Day 28)	-5.35 (13.50)	-8.46 (12.05)	0.1975	-7.89 (12.62)	0.0484	0.7463
AbsΔ (Day 56)	-8.38 (13.75)	-15.29 (13.72)	0.0006	-19.68 (14.91)	< 0.0001	0.0315
Abdominal distension
Day 0	65.08 (18.11)	66.31 (15.11)		63.07 (14.34)
AbsΔ (Day 28)	-8.66 (18.19)	-14.69 (17.68)	0.0600	-18.55 (22.62)	< 0.0001	0.1849
AbsΔ (Day 56)	-14.00 (20.76)	-29.33 (21.64)	< 0.0001	-35.45 (24.00)	< 0.0001	0.0598
Bowel habits
Day 0	68.32 (15.64)	69.35 (13.70)		66.72 (14.55)
AbsΔ (Day 28)	-6.45 (12.02)	-14.36 (18.66)	0.0020	-19.52 (21.48)	< 0.0001	0.0714
AbsΔ (Day 56)	-11.19 (16.63)	-27.73 (19.54)	< 0.0001	-32.31 (25.12)	< 0.0001	0.1561
Effect on quality of life
Day 0	67.13 (15.85)	68.90 (14.47)		66.62 (12.85)
AbsΔ (Day 28)	-5.97 (12.03)	-13.40 (17.48)	0.0060	-19.08 (21.13)	< 0.0001	0.0395
AbsΔ (Day 56)	-10.86 (15.74)	-27.19 (19.19)	< 0.0001	-32.81 (23.66)	< 0.0001	0.0690

¹ANCOVA using Dunnett’s test adjustment with treatment as factor and baseline as covariate vs placebo.

²Two-sample t-test comparing dose groups.

IBS-SSS: Irritable bowel syndrome-severity scoring system; AbsΔ: Absolute change; L. plantarum: Lactiplantibacillus plantarum.

Table 3 Abdominal pain severity, quality of life, and perceived stress scores over the intervention period

	Placebo (n = 104)	L. plantarum 1B (n = 104)		L. plantarum 10B (n = 99)
	mean (SD)	mean (SD)	P vs Placebo1	mean (SD)	P vs Placebo1	P vs 1B dose2
APS-NRS score
Day 0	7.14 (0.69)	7.14 (0.77)		7.17 (0.86)
AbsΔ (Day 28)	-0.61 (1.12)	-0.87 (1.06)	0.1356	-0.92 (0.90)	0.0733	0.7089
AbsΔ (Day 56)	-0.94 (1.36)	-1.83 (1.38)	< 0.0001	-2.39 (1.47)	< 0.0001	0.0057
IBS-QoL total score
Day 0	36.19 (17.97)	37.83 (17.25)		37.54 (17.02)
AbsΔ (Day 28)	4.20 (14.19)	8.82 (17.38)	0.0208	17.65 (19.47)	< 0.0001	0.0009
AbsΔ (Day 56)	4.90 (14.29)	17.47 (19.54)	< 0.0001	28.78 (23.64)	< 0.0001	0.0003
PSS score
Day 0	22.06 (4.29)	22.42 (4.12)		21.93 (4.31)
AbsΔ (Day 28)	-0.12 (3.92)	-2.38 (4.54)	< 0.0001	-2.76 (4.69)	< 0.0001	0.5690
AbsΔ (Day 56)	-0.46 (4.14)	-4.33 (6.51)	< 0.0001	-5.59 (6.43)	< 0.0001	0.1708

¹ANCOVA using Dunnett’s test adjustment with treatment as factor and baseline as covariate vs placebo.

²Two-sample t-test comparing dose groups.

APS-NRS: Abdominal pain severity-numeric rating scale; IBS-QoL: Irritable bowel syndrome-quality of life; PSS: Perceived stress scale; AbsΔ: Absolute change; L. plantarum: Lactiplantibacillus plantarum.