Effect of Lactic Acid Bacteria-Fermented Soy Milk Extract (LEX) on Urinary 3-Indoxyl Sulfate in Japanese Healthy Adult Women: An Open-Label Pilot Study

Figures & data

Table 1 Profile of Participants Enrolled in This Study

Item	Value
Sex	Female
Age	44.9 (2.8)^*
Presence of pregnancy	None
Presence of chronic disease	None
Ingestion of medicine	None
Frequency of defecation (self-assessment)	9 (30%) once/week, 21 (70%) once/2–3 days
Stool volume (self-assessment)	2 (6.7%) very few, 20 (66.7%) few
Urinary 3-indoxyl sulfate level	141.0 (60.9)^*μg/mg creatinine

Note:

* Values are presented as mean (SD) unless otherwise specified.

Figure 1 Trial participant tracking flowchart.

Figure 2 Changes in urinary 3-indoxyl sulfate levels.

Abbreviation: Cr, creatinine.
Notes: (A) Change with time from start of ingestion of the test article (n = 30). Statistical significance was determined using paired t-tests with Bonferroni correction coefficient. Significant differences from the initial values: **p < 0.01. Error bars indicate standard error. (B) Relationship between the initial urinary 3-indoxyl sulfate levels and the amount of change. Pearson’s correlation coefficient was 0.7407 (p < 0.001).

Table 2 Hierarchical Analysis of Changes in 3-Indoxyl Sulfate Values from the Initial 3-Indoxyl Sulfate Values

Class ^*1	Week	3-Indoxyl Sulfate (μg/mg creatinine)		p-value (Measured Value) vs 0w	p-value (Change Value) vs < 100
		Measured Value	Change Value
<100 (n = 8)	0w	75.84 (10.00)	–	–	–
	2w	86.92 (18.83)	11.07 (13.26)	0.484 ^*2	–
	4w	80.99 (9.74)	5.15 (14.78)	0.575 ^*2	–
100–150 (n = 10)	0w	122.35 (5.58)	–	–	–
	2w	99.27 (18.26)	–23.35 (17.78)	0.181 ^*3	0.068 ^*4
	4w	101.87 (11.38)	–20.48 (13.42)	0.122 ^*3	0.192 ^*5
>150 (n = 12)	0w	199.86 (14.16)	–	–	–
	2w	168.45 (25.20)	–31.41(32.78)	0.038 ^*3	0.157 ^*4
	4w	124.27 (19.37)	–75.59 (24.17)	0.007 ^*3	0.008 ^*5

Notes: Values are presented as mean (SE) unless otherwise specified.

* 1 classification by 3-indoxyl sulfate initial value. *2 Wilcoxon signed-rank test, *3 paired t-test, *4 Mann-Whitney U-test, *5 unpaired t-test.

Figure 3 Changes in the constipation assessment scale and self-assessment of physical condition.

Abbreviation: CAS, Constipation Assessment Scale.
Notes: (A) CAS score. (B) Physical condition score. The score range is 0–24 points for the CAS and 0–30 points for the physical condition score, with lower scores being better. Statistical significance was determined using the Wilcoxon signed-rank test with Bonferroni correction coefficient. Significant differences from the initial values: *p < 0.05, **p < 0.01, ***p < 0.001. n = 30.

Table 3 Changes in the Number of Defecations, Stool Volume, and Stool or Flatulence Odor During the Test Period

Item	Class	Test Period		p-value^*
		0–1 w	3–4 w
Number of defecations (per week)	All (n = 30)	5.87 (0.50)	6.00 (0.49)	0.663
	≦4 (n = 10)	2.60 (0.27)	3.50 (0.40)	0.043
	>4 (n = 20)	7.50 (0.35)	7.25 (0.51)	0.485
Single defecation volume (egg scale, weekly average)	All (n = 30)	1.89 (0.14)	2.16 (0.21)	0.107
	≦1.5 (n = 12)	1.19 (0.10)	1.53 (0.16)	0.037
	>1.5 (n = 18)	2.37 (0.12)	2.58 (0.19)	0.379
Odor evaluation scale	All (n = 30)	3.09 (0.16)	2.87 (0.16)	0.233
	≧3 (n = 19)	3.56 (0.15)	3.16 (0.17)	0.017
	≧4 (n = 7)	4.31 (0.16)	3.41 (0.38)	0.028
	<3 (n = 11)	2.27 (0.17)	2.37 (0.39)	0.386

Notes: Values are presented as mean (SE) unless otherwise specified.

* Wilcoxon signed-rank test.

Table 4 Changes in Each Items of Phisical Condition During the Test Period

Item	Test Period		p-value^*
	0 Weeks	4 Weeks
Skin condition	2.47 (0.14)	2.03 (0.17)	0.013
Quality of sleep	2.37 (0.13)	1.87 (0.15)	0.004
Morning awakening	2.67 (0.17)	2.27 (0.17)	0.005
Mood	2.10 (0.20)	1.90 (0.14)	0.258
Appetite	1.00 (0.14)	0.90 (0.13)	0.445
Tone of body	2.40 (0.18)	2.07 (0.16)	0.068
Total	13.00 (0.61)	11.03 (0.67)	0.005

Notes: Values are presented as mean (SE) unless otherwise specified.

* Wilcoxon signed-rank test.

Figure 4 Correlation plot of several test parameters.

Abbreviations: Cr, creatinine; CAS, Constipation Assessment Scale.
Notes: (A) Urinary 3-indoxyl sulfate versus self-assessment of physical condition, including CAS. Pearson’s correlation coefficient was 0.2135 (p = 0.043). (B) Self-assessment of physical condition within the CAS vs the feeling of refreshment during defecation. Spearman’s rank correlation was 0.3120 (p = 0.003). (C) Stool volume (single defecation) vs the feeling of refreshment during defecation. Spearman’s rank correlation coefficient was 0.5193 (p = 0.001).