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Page 6 of 14 Tian et al. Microbiome Res Rep 2024;3:49 https://dx.doi.org/10.20517/mrr.2024.33

Table 1. Medication and demographic information
Variable CCFM6432 (n = 20) Placebo (n = 19) Statistic value P value
Age, Mean ± SD 37.40 ± 14.31 41.79 ± 17.81 1.554 0.416 a
b
Sex, n (%) Male 7 5 0.345 0.557
Female 13 14
Race, n (%) Chinese, Han nationality 20 (100) 19 (100) N/A N/A
a
BMI Too light 1 (5) 3 (15) 1.284 0.45
Normal 13 (68) 10 (50)
Overweight 5 (27) 7 (35)
Medication type, n (%) Mirtazapine 2 (10) 3 (16) 0.292 0.589 b
b
Citalopram 1 (5) 4 (21) 2.246 0.134
Lorazepam 3 (15) 5 (26) 0.765 0.381 b
b
Zopiclone 0 (0) 1 (5) 1.08 0.298
b
Oxazepam 2 (10) 1 (5) 0.308 0.579
b
Venlafaxine 1 (5) 1 (5) 0.001 0.970
b
Sertraline hydrochloride 0 (0) 2 (11) 2.219, 0.136
Zolpidem tartrate tablets 1 (5) 1 (5) 0.001 0.970 b
b
Duloxetine 1 (5) 1 (5) 0.001 0.970
Tandospirone 2 (10) 1 (5) 0.308 0.579 b
b
Paroxetine 0 (0) 1 (5) 1.08 0.299
Olanzapine 1 (5) 1 (5) 0.001 0.970 b
b
Fluvoxamine maleate tablets 0 (0) 2 (11) 2.219 0.136
Aripiprazole 1 (5) 1 (5) 0.001 0.970 b
b
Quetiapine 2 (10) 0 (0) 2.003 0.157
b
Clonazepam 1 (5) 0 (0) 0.975 0.323
b
Unknown 4 (25) 4 (21) 0.007 0.935
b
Smokers, n (%) Smoker 3 (15) 5 (26) 0.765 0.381
a b
Statistical analysis by t-test. Statistical analysis by chi-square test. n: Number of participants; N/A: not available. BMI: body mass index.
the probiotics, we analyzed the inter-group differences in the changes in scores before and after treatment,
rather than focusing solely on within-group changes in scores before and after treatment. The results
showed that the HADS score in the CCFM6432 group was significantly lower after treatment than before
(P = 0.001), while there was no significant change in the HADS score in the placebo group before and after
treatment (P = 0.174; Figure 2A). Moreover, compared to the placebo group, the CCFM6432 group showed
a greater decrease in scores after treatment (P < 0.001; Figure 2A). Additionally, in terms of the “Anxiety” or
“Depression” subscale scores, CCFM6432 showed a better effect on reducing the scores (P = 0.03 and P =
0.005, respectively; Figure 2B). Analysis of the SAS scores showed that there was no significant change in
scores before and after treatment in the placebo group (P = 0.856 and P = 0.071, respectively), but the
decrease in scores was greater in the CCFM6432 group (P = 0.052; Figure 2C).

Patients with depression often experience sleep and gastrointestinal issues throughout the course of the
disease, with reported comorbidity rates as high as 90% for sleep disorders and about 60% for
gastrointestinal dysfunction [25,26] . We evaluated the sleep quality and gastrointestinal function of patients
using the PSQI and GSRS scales, respectively. Unlike the placebo (P = 0.156), only CCFM6432 treatment
significantly reduced PSQI scores (P = 0.001); however, there was no significant difference in score changes
before and after treatment between the two groups (P = 0.149; Figure 2D). Both placebo and CCFM6432
had no significant effect on patient gastrointestinal function [Figure 2E and F].