Published online Dec 12, 2023. doi: 10.4292/wjgpt.v14.i5.39
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
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterized by recurrent abdominal pain and changes in bowel habits. Diarrhea predominant IBS (IBS-D) is the most prevalent subtype, causing chronic and debilitating diarrhea. This study explores the potential benefits of an amino acid based medical food, enterade® IBS-D, to address nutritional deficits in IBS-D patients and improve their gastrointestinal symptoms, aiming to provide an additional means to management.
The motivation to perform this research was to discover additional therapies to aid in the management of chronic diarrhea and associated symptomology resulting from IBS-D.
The study primarily focused on the tolerability of the amino acid based medical food by monitoring adverse events (AEs) reported by participants. Secondary outcomes were assessed using a number of clinical criteria, including changes in stool consistency [Bristol Stool Form Scale (BSFS)], reduction in abdominal pain and discomfort, improvement in bowel urgency, and changes in the overall IBS-Severity Scoring System. The study considered both statistical significance and clinical relevance as recommended by the Food and Drug Administration for IBS-related assessments.
The study used a decentralized, open-label, single-arm design, with data collected electronically through the Laina Clinical Research Platform during a 2-week baseline assessment and a subsequent 2-week intervention period, where participants consumed enterade® IBS-D. The study included adults aged 18-65, diagnosed with IBS-D in the United States. Participants were evaluated during a 2-week run-in period to confirm their diagnosis using Rome IV criteria. Eligible participants needed to experience diarrhea at least four times weekly (BSFS types 6 and 7), along with abdominal pain/discomfort and a Functional Bowel Disorder Severity Index score above 60. Exclusion criteria included other IBS subtypes, gastrointestinal disorders, pregnancy/breastfeeding, allergies to the test product components, and anticipated medication changes that could affect bowel habits. Outcome measures included daily symptom diaries, the IBS-Severity Scoring System, and the Global Improvement Survey (GIS) from the Rome Foundation.
The study involved 100 participants with IBS-D who completed a 2-week intervention period. All participants met ROME IV criteria for IBS-D, and their baseline IBS severity scoring system (IBS-SSS) score and FBDSI scores indicated moderate to severe symptomology. Tolerance to the amino acid-based medical food was exceptional, with no dropouts or discontinuations, and only two mild AEs reported. Responder analysis for secondary outcomes revealed that 40% of participants achieved a 50% or more decrease in days with type 6-7 bowel movements. Additionally, 53% and 55% experienced clinically meaningful reductions in pain and discomfort, respectively. About 25% of participants achieved meaningful responses in both pain/stool consistency or discomfort/stool consistency. Fifty-eight percent of participants showed improvements in urgency. IBS-SSS data demonstrated significant improvement, with 75% experiencing a reliable clinical score improvement, 51% achieving a ≥ 95-point score improvement, and a category shift from severe to moderate or mild in 69% of participants. Furthermore, 76% reported relief on the GIS after 14 d of amino acid beverage consumption.
The study suggests that adding an amino acid-based medical food to the standard care for IBS-D patients is practical and well-tolerated. The improvements in gastrointestinal symptoms were statistically significant and comparable to longer nutrition intervention trials, making this amino acid beverage a promising adjunct for relieving IBS-D symptoms.
While patient reported outcomes in IBS research are crucial endpoints, future studies that include collection of biological samples, such as direct blood and fecal markers, will supplement and strengthen the conclusions that have been drawn from this pragmatic study.