Efficacy of Pediococcus acidilactici CCFM6432 in alleviating anhedonia in major depressive disorder: A randomized controlled trial

Table 1 Baseline demographic and clinical characteristics of the two groups (mean ± SD)

	CCFM6432 (n = 27)	Placebo (n = 28)	Statistics	P value
Sex (M/F)	10/17	11/17	0.029 (χ²)	0.864
Age (years)	27.30 (6.94)	31.29 (11.29)	-1.571 (t)	0.120
BMI	22.27 (3.45)	22.37 (3.88)	-0.098 (t)	0.922
Handedness (R/L/M)	25/1/1	25/2/1	0.315 (χ²)	0.854
Education level (years)	14.74 (2.36)	13.96 (3.32)	0.997 (t)	0.323
Disease course (years)	3.74 (4.22)	5.70 (5.10)	-1.239 (z)	0.215
Number of episodes	1.85 (0.91)	2.29 (1.38)	-1.055 (z)	0.292
Antidepressant DDD	1.49 (1.07)	1.40 (1.29)	-0.606 (z)	0.544
SSRI/SNRI/NaSSA/SARI	15/7/2/3	16/7/1/4	0.490 (χ²)	0.921

BMI: Body mass index; DDD: Defined daily dose; F: Female; M: Male; NaSSA: Noradrenergic and specific serotonergic antidepressant; R/L/M: Right/Left/Mixed; SARI: Serotonin receptor antagonist and reuptake inhibitor; SNRI: Serotonin-norepinephrine reuptake inhibitor; SSRI: Selective serotonin reuptake inhibitor.

Table 2 Between-group comparison of clinical assessments using mixed-design analysis of variance (mean ± SD)

	CCFM6432 (n = 27)	Placebo (n = 28)	P value1	P value2	P value3
HAMA_Baseline	19.07 (7.80)	18.11 (9.39)	0.011	0.455	< 0.001
HAMA_Follow-up	9.04 (5.89)	12.89 (7.95)
HAMD_Baseline	21.74(7.07)	21.04 (8.69)	0.013	0.492	< 0.001
HAMD_Follow-up	9.89 (5.80)	13.25 (8.72)
TEPS_Baseline	70.07 (11.89)	71.89 (13.87)	0.041	0.645	0.007
TEPS_Follow-up	78.00 (13.92)	73.07 (15.22)
ANT_Baseline	30.56 (6.45)	33.00 (7.09)	0.015	0.981	0.009
ANT_Follow-up	35.74 (7.15)	33.21 (8.01)
CON_Baseline	39.52 (7.63)	38.89 (9.33)	0.293	0.486	0.031
CON_Follow-up	42.26 (8.03)	39.86 (9.16)

¹P-value for the group × time interaction.

²P-value for the main effect of group.

³P-value for the main effect of time.

ANT: Anticipatory; CON: Consummatory; HAMA: Hamilton Anxiety Rating Scale; HAMD: Hamilton Depression Rating Scale; TEPS: Temporal Experience of Pleasure Scale.