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/
World J Gastrointest Pharmacol Ther. Sep 5, 2024; 15(5): 97330 Published online Sep 5, 2024. doi: 10.4292/wjgpt.v15.i5.97330
Effect of KiwiBiotic on functional constipation and related symptoms: A prospective, single-center, randomized, comparative, crossover study
Ashwin D Porwal, Paresh M Gandhi, Deepak K Kulkarni, Gajanan B Bhagwat, Pravin P Kamble
Ashwin D Porwal, Paresh M Gandhi, Deepak K Kulkarni, Department of Proctology, Healing Hands Clinic, Mahārāshtra, Pune 411001, India
Gajanan B Bhagwat, Pravin P Kamble, R&D Center, Healing Hands and Herbs Pvt. Ltd., Mahārāshtra, Pune 411002, India
Co-first authors: Ashwin D Porwal and Paresh M Gandhi.
Author contributions: Porwal AD, Gandhi PM, Kulkarni DK and Bhagwat GB conceptualized and designed the study; Kamble PP and Bhagwat GB wrote the manuscript; Porwal AD and Bhagwat GB revised the manuscript; Kamble PP, Bhagwat GB and Porwal AD confirmed the authenticity of the data. All authors have read and approved the final manuscript. Porwal AD and Gandhi PM contributed equally to this work as co-first authors.
Institutional review board statement: The Healing Hands Institutional Ethic Committee approved the study.
Clinical trial registration statement: The study was approved by the Clinical Trial Registry of India (CTRI/2023/09/058081, dated 27th September 2023).
Informed consent statement: All study participants, or their legal guardians, provided informed written consent prior to study enrolment.
Conflict-of-interest statement: All authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at drashwinporwal@healinghandsclinic.co.in. Participants gave informed consent for data sharing. No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: 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
Received: May 28, 2024 Revised: July 25, 2024 Accepted: August 2, 2024 Published online: September 5, 2024 Processing time: 97 Days and 22.3 Hours
Abstract
BACKGROUND
Functional constipation (FC) is a common gastrointestinal disorder characterized by abdominal pain and bloating, which can greatly affect the quality of life of patients. Conventional treatments often yield suboptimal results, leading to the exploration of alternative therapeutic approaches.
AIM
To evaluate the efficacy of KiwiBiotic in the management of FC and related symptoms.
METHODS
This prospective, interventional, single-center, crossover study compared the safety and effectiveness of KiwiBiotic®vs psyllium husk in managing FC, abdominal pain, and bloating. Participants diagnosed with FC were randomly assigned to receive KiwiBiotic or psyllium husk during the two treatment periods, with a 14-day washout period between them.
RESULTS
Seventy participants were enrolled, 32 of whom received KiwiBiotic followed by psyllium husk, and 33 received KiwiBiotic. KiwiBiotic showed superiority over psyllium husk in alleviating abdominal pain and bloating, as evidenced by significantly lower mean scores. Furthermore, KiwiBiotic resulted in more than 90.0% of patients experiencing relief from various constipation symptoms, while psyllium husk showed comparatively lower efficacy.
CONCLUSION
KiwiBiotic is an effective treatment option for FC, abdominal pain, and bloating, highlighting its potential as a promising alternative therapy for patients with FC and its associated symptoms.
Core Tip: Functional constipation (FC) significantly affects the quality of life of patients due to symptoms such as abdominal pain and bloating. Conventional treatments often fail, necessitating alternative therapies. Phytotherapeutic product KiwiBiotic has emerged as a promising alternative treatment for FC, abdominal pain, and bloating, offering superior efficacy, improved quality of life, and higher patient satisfaction than conventional options such as psyllium husk. Its effectiveness in symptom relief, demonstrated in more than 90% of patients, highlights its potential as a safe and comprehensive therapeutic option.
