Effectiveness of an amino acid beverage formulation in diarrhea-predominant irritable bowel syndrome: A pragmatic real-world study

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.

Keywords: Diarrhea-predominant irritable bowel syndrome, Amino acid beverage formulation, Pragmatic real-world study, Medical food, Bristol Stool Form Scale, Irritable Bowel Syndrome – Severity Scoring System

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.