World J Gastrointest Pharmacol Ther. 2023 Dec 12;14(5):39-49. doi: 10.4292/wjgpt.v14.i5.39.

Samantha E Niles ¹, Phil Blazy ², Samuel N Cheuvront ², Robert W Kenefick ², Sadasivan Vidyasagar ^2 3, Adam B Smith ², Neil Fawkes ², William Denman ^2 4

Author information

¹Department of Research and Development, Entrinsic Bioscience, Norwood, MA 02062, United States. sniles@entrinsic.com.

²Department of Research and Development, Entrinsic Bioscience, Norwood, MA 02062, United States.

³Department of Radiation Oncology, University of Florida, Gainesville, FL 32611, United States.

⁴Department of Anesthesiology, Massachusetts General Hospital, Boston, MA 02114, United States.

Abstract

Background: Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects; particularly, diarrhea-predominant symptoms. Irritable bowel syndrome (IBS) is a gastrointestinal disorder that affects up to 9% of people globally, with diarrhea predominant IBS (IBS-D) being the most prevalent subtype. Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.

Aim: To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.

Methods: This is a pragmatic, real world, open label, single arm study comparing a 2-week baseline assessment to a 2-week intervention period. One hundred adults, aged 18 to 65 years, with IBS-D, according to Rome IV criteria, were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care. The primary outcome was an assessment of tolerability after 2-weeks of consumption, while secondary outcomes included changes in stool consistency (Bristol Stool Form Scale), severity of abdominal pain & discomfort, symptoms of urgency, Global Improvement Survey (GIS), and the IBS severity scoring system (IBS-SSS).

Results: The test product was well-tolerated as each participant successfully completed the full 14-day trial, and there were no instances of dropouts or discontinuation of the study product reported. Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements (IBS-D stool consistency responders). Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores, and 55% experienced the same for mean weekly discomfort scores (IBS-D pain and discomfort responders). Participants experienced a mean -109.4 (95% confidence interval: -130.1, -88.8) point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of > 95 points. An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants. For functional symptoms, 76% of participants reported symptom relief on the GIS.

Conclusion: The amino acid-based medical food was well-tolerated, when added to the standard of care, and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.