Effect of KiwiBiotic on functional constipation and related symptoms: A prospective, single-center, randomized, comparative, crossover study

Table 1 Patient characteristics at baseline (n = 70), n (%)

Demographics	KiwiBiotic	Psyllium husk	Total	P value
Gender				0.138a
Female	25 (71.43)	19 (54.29)	44 (62.86)
Male	10 (28.57)	16 (45.71)	26 (37.14)
Age (year)				0.156
Mean (SD)	41.4 (10.96)	45.83 (14.84)	43.61 (13.14)
Range	18-65	23-73	18-73
Weight (kg)				0.064
Mean (SD)	58.89 (7.88)	62.41 (8.03)	60.65 (8.092)
Range	42-80.9	47-79.3	42-80.9
Height (m)				0.123
Mean (SD)	162.1 (6.68)	164.73 (7.54)	163.42 (7.2)
Range	152-176.7	152-177	152-177
BMI (kg/m2)				0.291
Mean (SD)	22.37 (2.40)	23.00 (2.56)	22.68 (2.48)
Range	17.3-28.8	17.3-28.3	17.3-28.8

^aChi-square test.

BMI: Body mass index.

Table 2 Descriptive statistics for abdominal pain at visit 2 and visit 4

	Sequence	n	Period 1		Period 2
			Mean	SD	Mean	SD
Abdominal pain	KP	32	1.4688	0.87931	6.2188	2.4591
	PK	33	7.2121	2.342	1.6667	1.0206

KP: KiwiBiotic during period 1 and psyllium husk during period 2; PK: Psyllium husk during period 1 and KiwiBiotic during period 2.

Table 3 Cross-over effects and analysis details for abdominal pain

	Effect	SE	DF	T value	P value	95%CI	Significance
Carryover	-1.1913	0.69641	63	-1.7106	0.092	-2.5830, 0.20038	No
Treatment	-5.1477	0.28995	63	-17.754	0.000	-5.7271, -4.5683	Yes
Period	-0.39773	0.28995	63	-1.3717	0.175	-0.97714, 0.18169	No

DF: Degrees of freedom; CI: Confidence interval.

Table 4 Descriptive statistics for abdominal bloating at visit 2 and visit 4

	Sequence	n	Period 1		Period 2
			Mean	SD	Mean	SD
Abdominal bloating	KP	32	1.3125	0.7378	4.9375	1.7949
	PK	33	5.4848	1.8392	1.4545	0.66572

Table 5 Cross-over effects and analysis details for abdominal blotting

	Effect	SE	DF	T value	P value	95%CI	Significance
Carryover	-0.68939	0.50583	63	-1.3629	0.178	(-1.7002, 0.32143)	No
Treatment	-3.8277	0.22994	63	-16.646	0.000	(-4.2872, -3.3681)	Yes
Period	-0.20265	0.22994	63	-0.88131	0.382	(-0.66216, 0.25686)	No

DF: Degrees of freedom; CI: Confidence interval.

Table 6 T-test for abdominal pain and abdominal bloating (one-sided)

	Mean (KiwiBiotic)	Mean (Psyllium husk)	SE	DF	T value	P value	Significance
Abdominal pain	1.5692	6.7231	0.28995	63	-17.754	< 0.05	Yes
Abdominal bloating	1.3846	5.2154	0.22994	63	-16.646	< 0.05	Yes

DF: Degrees of freedom.

Table 7 Assessment of functional constipation

Symptoms of functional constipation	Number of subjects experiencing symptom relief from functional constipation after consuming KiwiBiotic but not after psyllium husk	Number of subjects experiencing symptom relief from functional constipation after consuming psyllium husk but not after KiwiBiotic	P value for MC-Nemar’s test
Straining during more than ¼ 25% of excretion	39	1	< 0.05
Lumpy or hard stools (BSFS type 1 or 2) more than 25% of defecations	39	1	< 0.05
Sensation of incomplete evacuation of more than one-fourth (25%) of defecations	37	1	< 0.05
Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations	33	0	< 0.05
Manual manoeuvres to facilitate more than ¼ (25%) of defecation	33	1	< 0.05
Fewer than three spontaneous bowel movements per week	11	2	< 0.05

Table 8 Percentage of subjects improved their symptoms of functional constipation

Symptoms of functional constipation	After the KiwiBiotic treatment (%)	After the psyllium husk treatment (%)
Straining during more than ¼ 25% of excretion	91.0	32.0
Lumpy or hard stools (BSFS type 1 or 2) more than 25% of defecations	91.0	32.0
Sensation of incomplete evacuation of more than one-fourth (25%) of defecations	91.0	35.0
Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations	95.0	45.0
Manual manoeuvres to facilitate more than ¼ (25%) of defecation	94.0	45.0
Fewer than three spontaneous bowel movements per week	97.0	83.0

Table 9 Effect of treatments on gastrointestinal quality of life index and its domain and estimation for paired differences (two-sided)

	KiwiBiotic			Psyllium-husk
	Estimation for paired difference
GIQLI domains	Mean (SD)	95%CI	P value	Mean (SD)	95%CI	P value
GI-symptoms	-39.69 (6.3)	-41.264, -38.121	< 0.05	-10.78 (15.7)	-14.67, -6.90	< 0.05
Psychological	-10.19 (2.2)	-10.744, -9.626	< 0.05	-0.415 (5.5)	-1.787, 0.956	0.547
Physical	-16.71 (3.3)	-17.533, -15.883	< 0.05	-3.23 (7.1)	-4.999, -1.463	0.001
Social	-2.37 (3.6)	-3.262, -1.476	< 0.05	-0.077 (2.0)	-0.571, 0.417	0.757
Overall	-68.95 (10.5)	-71.56, -66.35	< 0.05	-14.51 (26.8)	-21.15, -7.86	< 0.05

CI: Confidence interval; GI: Gastrointestinal; GIQLI: Gastrointestinal quality of life index.

Table 10 Overall treatment evaluation score

Condition	KiwiBiotic (%)	Psyllium-husk
Resolved	55.38	0.00
Much better	41.54	9.23
Little better	3.08	13.85
The same	0.00	33.85
Worse	0.00	43.08