Porwal AD, Gandhi PM, Kulkarni DK, Bhagwat GB, Kamble PP. Effect of KiwiBiotic on functional constipation and related symptoms: A prospective, single-center, randomized, comparative, crossover study. World J Gastrointest Pharmacol Ther 2024; 15(5): 97330 [PMID: 39281263 DOI: 10.4292/wjgpt.v15.i5.97330]
Corresponding Author of This Article
Ashwin D Porwal, DNB, MBBS, Chief Doctor, Founder and CEO, Surgeon, Department of Proctology, Healing Hands Clinic, Millenium Star Extension, Dhole Patil Rd, Near Ruby Hall, Mahārāshtra, Pune 411001, India. drashwinporwal@healinghandsclinic.co.in
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Randomized Controlled Trial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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
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
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
Table 6T-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
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
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
Citation: Porwal AD, Gandhi PM, Kulkarni DK, Bhagwat GB, Kamble PP. Effect of KiwiBiotic on functional constipation and related symptoms: A prospective, single-center, randomized, comparative, crossover study. World J Gastrointest Pharmacol Ther 2024; 15(5): 97330