Case Control Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. Dec 12, 2023; 14(5): 39-49
Published online Dec 12, 2023. doi: 10.4292/wjgpt.v14.i5.39
Effectiveness of an amino acid beverage formulation in diarrhea-predominant irritable bowel syndrome: A pragmatic real-world study
Samantha E Niles, Phil Blazy, Samuel N Cheuvront, Robert W Kenefick, Sadasivan Vidyasagar, Adam B Smith, Neil Fawkes, William Denman
Samantha E Niles, Phil Blazy, Samuel N Cheuvront, Robert W Kenefick, Sadasivan Vidyasagar, Adam B Smith, Neil Fawkes, William Denman, Department of Research and Development, Entrinsic Bioscience, Norwood, MA 02062, United States
Sadasivan Vidyasagar, Department of Radiation Oncology, University of Florida, Gainesville, FL 32611, United States
William Denman, Department of Anesthesiology, Massachusetts General Hospital, Boston, MA 02114, United States
Author contributions: Niles SE, Cheuvront SN, Kenefick RW, and Fawkes N designed the research study; Niles SE, Blazy P, Cheuvront SN, Kenefick RW, Vidyasagar S, Smith AB, Fawkes N, and Denman W analyzed the data and wrote the manuscript; Denman W acted as the Principal Investigator; all authors have read and approve the final manuscript.
Institutional review board statement: The study was reviewed and approved by the Advarra Institutional Review Board (Approval No. Pro00065894).
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: All authors are employees of Entrinsic Bioscience LLC (EBS) and EBS was the research sponsor. Patent 174821-011205/PCT (PCT/US11/53265) is issued to EBS Holdings, and patent 174821-012001/PCT (PCT/US13/25294) is issued to EBS Holding.
Data sharing statement: All analyzed data are included in this published article. The original data are available upon reasonable request to the corresponding author.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Data sharing statement: Anonymized data is available by request.
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: Samantha E Niles, BSc, MS, Researcher, Department of Research and Development, Entrinsic Bioscience, 500 River Ridge Dr. 100, Norwood, MA 02062, United States. sniles@entrinsic.com
Received: September 29, 2023
Peer-review started: September 29, 2023
First decision: October 8, 2023
Revised: October 16, 2023
Accepted: November 15, 2023
Article in press: November 15, 2023
Published online: December 12, 2023
Processing time: 73 Days and 12 Hours
Core Tip

Core Tip: Amino-acid based medical foods have been shown to alleviate symptoms of drug induced gastrointestinal side effects, especially diarrhea severity. Diarrhea predominant irritable bowel syndrome (IBS-D) is a chronic gastrointestinal disorder that affects up to 9% of people worldwide. In this pragmatic, real-world study, an amino acid beverage was demonstrated to be tolerable and efficacious when used as an adjunct to standard of care for adults with IBS-D. Participants demonstrated improvements in both overall irritable bowel syndrome symptom severity and IBS-D symptoms within just two weeks. These results suggest that this amino acid-based beverage can be safely integrated into IBS-D standard of care for symptom improvement.