Effects of dietary fiber with Bacillus coagulans lilac-01 on bowel movement and fecal properties of healthy volunteers with a tendency for constipation

Figures & data

Table 1. Rome III diagnostic criteria for functionally constipation.¹⁾

Symptoms
Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
1. Must include 2 or more of the following:
a. Straining^a
b. Lumpy or hard stools^a
c. Sensation of incomplete evacuation^a
d. Sensation of anorectal obstruction/blockage^a
e. Manual maneuvers to facilitate^a
f. Fewer than 3 defecations per week
2. Loose stools are rarely present without the use of laxatives
3. There are insufficient criteria for irritable bowel syndrome

^a  ≥25% of defecations.

Fig. 1. Experimental schedule.

Table 2. Fecal properties and symptoms during defecation.

Fecal properties	Score
Color^a	1. Blackish brown (No. 582), 2. Dark brown (No. 311), 3. Brown (No. 308),
	4. Ochre (No. 240), 5. Orange (No. 205)
Shape^b
	1. Watery, no solid pieces
	2. Fluffy pieces with ragged edges, a mushy stool
	3. Soft blobs with clear cut edges
	4. Like a sausage or snake, smooth and soft
	5. Like a sausage or snake but with cracks on its surface
	6. Sausage-shaped, but lumpy
	7. Separate hard lumps, like nuts
Size	1. <1 unit, 2. 1 unit, 3. 2 units, 4. 3 units, 5. 4 units, 6. 5 units, 7. >5 units
Odor	1. Very strong, 2. Strong, 3. A little strong, 4. Odorless
Straining	1. Very difficult, 2. A little difficult, 3. Easy
Sensation of incomplete evacuation	1. Very unrefreshing, 2. A little unrefreshing, 3. Refreshing, 4. Very refreshing

Notes: Except for fecal shape, scores went from ‘worse’ to ‘better,’ and for fecal shape, scores were from 1 (softer) to 7 (harder) in incremental steps.

^a According to a color sample book (Color Guide 19th ed., Dainippon Ink and Chemicals, Tokyo).

^b According to the Bristol stool form scale.^12).

Table 3. Average per-day scores of fecal properties.

	Group	Size		Shape		Color		Odor
		Week 0	Week 2	Week 0	Week 2	Week 0	Week 2	Week 0	Week 2
All subjects (n = 268)	Placebo (Okara powder)	2.87 ± 0.13	3.30 ± 0.12^*	3.56 ± 0.12	3.40 ± 0.09	2.34 ± 0.07	2.50 ± 0.07	2.27 ± 0.07	2.47 ± 0.06
	Test food (Lilac LAB)	2.80 ± 0.13	3.22 ± 0.10^*	3.43 ± 0.12	3.60 ± 0.09	2.24 ± 0.08	2.45 ± 0.06	2.19 ± 0.08	2.49 ± 0.06^**
Functionally constipated subjects (n = 137)	Placebo (Okara powder)	2.85 ± 0.17	3.18 ± 0.15	3.82 ± 0.17	3.58 ± 0.13	2.33 ± 0.09	2.48 ± 0.09	2.33 ± 0.11	2.49 ± 0.08
	Test food (Lilac LAB)	2.28 ± 0.16	3.10 ± 0.14^**	3.40 ± 0.18	3.69 ± 0.14	1.97 ± 0.10	2.37 ± 0.07^**	1.94 ± 0.10	2.46 ± 0.09^**
Non-functionally constipated subjects (n = 131)	Placebo (Okara powder)	2.89 ± 0.18	3.42 ± 0.18	3.28 ± 0.16	3.20 ± 0.13	2.36 ± 0.11	2.52 ± 0.10	2.21 ± 0.10	2.46 ± 0.09
	Test food (Lilac LAB)	3.31 ± 0.18	3.34 ± 0.15	3.45 ± 0.16	3.51 ± 0.13	2.51 ± 0.11	2.53 ± 0.09	2.43 ± 0.12	2.52 ± 0.09

Notes: Scores refer to Table 2. Values are mean ± SD. The average scores in the week before intake (Week 0) and the second week after intake (Week 2) per day were respectively calculated. Using these values, we examined the differences between before and after the ingestion with the Gemes–Howell test.

^* p < 0.05, significantly different from Week 0.

^** p < 0.01, significantly different from Week 0.

Table 4. Average per-day scores of defecation frequency and symptoms during defecation.

	Group	Straining		Sensation of incomplete evacuation		Defecation frequency
		Week 0	Week 2	Week 0	Week 2	Week 0	Week 2
All subjects (n = 268)	Placebo	1.65 ± 0.06	1.78 ± 0.05	1.88 ± 0.07	2.02 ± 0.06	0.99 ± 0.04	1.05 ± 0.04
	(Okara powder)
	Test food	1.64 ± 0.06	1.79 ± 0.05	1.82 ± 0.07	2.12 ± 0.06^**	1.08 ± 0.06	1.20 ± 0.05
	(Lilac LAB)
Functionally constipated subjects (n = 137)	Placebo	1.58 ± 0.07	1.75 ± 0.07	1.80 ± 0.08	2.00 ± 0.08	0.97 ± 0.05	1.02 ± 0.05
	(Okara powder)
	Test food	1.39 ± 0.08	1.73 ± 0.07^**	1.55 ± 0.08	2.09 ± 0.09^**	0.91 ± 0.06	1.21 ± 0.08^**
	(Lilac LAB)
Non-functionally constipated subjects (n = 131)	Placebo	1.72 ± 0.09	1.82 ± 0.08	1.97 ± 0.10	2.05 ± 0.09	1.02 ± 0.06	1.09 ± 0.06
	(Okara powder)
	Test food	1.90 ± 0.09	1.86 ± 0.07	2.08 ± 0.10	2.15 ± 0.09	1.24 ± 0.11	1.18 ± 0.06.
	(Lilac LAB)

Notes: Scores refer to Table 2. Values are mean ± SD. The average scores in the week before intake (Week 0) and the second week after intake (Week 2) per day were respectively calculated. Using these values, we examined the differences between before and after the ingestion with the Gemes–Howell test.

^* p < 0.05, significantly different from Week 0.

^** p < 0.01, significantly different from Week 0.

Table 5. Changes in average scores of fecal properties.

	Group	Size	Shape	Color	Odor
All subjects (n = 268)	Placebo (Okara powder)	0.43 ± 0.13	−0.16 ± 0.12	0.16 ± 0.08	0.20 ± 0.08
	Test food (Lilac LAB)	0.43 ± 0.14	0.17 ± 0.13	0.21 ± 0.09	0.31 ± 0.09
Functionally constipated subjects (n = 137)	Placebo (Okara powder)	0.33 ± 0.17	−0.24 ± 0.19	0.15 ± 0.11	0.16 ± 0.12
	Test food (Lilac LAB)	0.82 ± 0.20^*	0.28 ± 0.18^*	0.41 ± 0.11	0.52 ± 0.11
Non-functionally constipated subjects (n = 131)	Placebo (Okara powder)	0.53 ± 0.20	−0.07 ± 0.15	0.16 ± 0.13	0.24 ± 0.10
	Test food (Lilac LAB)	0.03 ± 0.19	0.06 ± 0.19	0.02 ± 0.14	0.09 ± 0.14

Note:

Scores refer to Table 2. Values are mean ± SD. The average scores in the week before intake (Week 0) and the second week after intake (Week 2) per day were respectively calculated. Using a variation of these values, we examined the differences between the placebo and test groups with Mann–Whitney’s U-test.

^* p < 0.05, significantly different from the placebo group.

Fig. 2. Changes of average score in Week 0 and Week 2 of the 137 functionally constipated subjects.

Notes: (a) Fecal size, (b) fecal shape, (c) fecal color, and (d) odor. Box plots show 25th and 75th percentiles, median and range. The average per-day scores in the week before intake (Week 0) and the second week after intake (Week 2) were respectively calculated. Using a variation of these values, we examined the differences between the placebo and test groups with Mann–Whitney’s U-test. *p < 0.05 compared to the placebo group.

Table 6. Changes in average scores of defecation frequency and symptoms during defecation.

	Group	Straining	Sensation of incomplete evacuation	Defecation frequency
All subjects (n = 268)	Placebo	0.13 ± 0.06	0.14 ± 0.07	0.06 ± 0.05
	(Okara powder)
	Test food	0.15 ± 0.07	0.30 ± 0.09	0.12 ± 0.07
	(Lilac LAB)
Functionally constipated subjects (n = 137)	Placebo	0.17 ± 0.09	0.20 ± 0.09	0.05 ± 0.06
	(Okara powder)
	Test food	0.34 ± 0.09	0.54 ± 0.11^*	0.30 ± 0.09^*
	(Lilac LAB)
Non-functionally constipated subjects (n = 131)	Placebo	0.09 ± 0.10	0.08 ± 0.10	0.07 ± 0.07
	(Okara powder)
	Test food	−0.04 ± 0.10	0.07 ± 0.13	−0.06 ± 0.09
	(Lilac LAB)

Notes: Scores refer to Table 2. Values are mean ± SD. Average per-day scores in the week before intake (Week 0) and the second week after intake (Week 2) were respectively calculated. Using a variation of these values, we examined the differences between placebo and test groups with Mann–Whitney’s U-test.

^* p < 0.05 compared to the placebo group.

Fig. 3. Changes of average score in Week 0 and Week 2 of functionally constipated subjects.

Notes: (a) Straining, (b) sensation of incomplete evacuation, and (c) defecation frequency. Box plots show 25th and 75th percentiles, median and range. Average per-day scores in the week before intake (Week 0) and the second week after intake (Week 2) were respectively calculated. Using a variation of these values, we examined the differences between the placebo and test groups with Mann–Whitney’s U-test. *p < 0.05 compared to the placebo group.

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