Enzyme Supplement May Ease IBS Symptom Severity

An oral enzyme supplement appeared to reduce symptom severity for adults with irritable bowel syndrome (IBS), a prospective, single-arm study showed.

Among over 400 patients taking the enzyme blend targeting FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols), mean IBS Symptom Severity Score (IBS-SSS) decreased from 269.7 points at baseline to 167.3 points at 4 weeks (P<0.001), reported Eden Koo, MD, of the University of Michigan in Ann Arbor.

In addition, 69% of patients had a clinically meaningful improvement (defined as a ≥50-point reduction in IBS-SSS), and 52% achieved a ≥100-point reduction.

“We hope that this FODMAP-targeting enzyme strategy may eventually help liberalize diet, while maintaining symptom control,” Koo said at the American College of Gastroenterology annual meeting in Nashville, Tennessee.

However, randomized trials are needed “before we can fully recommend this as an effective therapy, or even compare this to the FODMAP diet itself,” he added.

FODMAPs can trigger abdominal pain, bloating, and altered bowel habits in IBS. The low-FODMAP diet has three steps: a restriction phase in which patients abstain from foods containing FODMAPs, followed by a reintroduction phase in which patients slowly introduce FODMAP groups back into their diet to determine which group may trigger symptoms, and finally a personalization phase in which those foods are avoided or limited.

“The main challenge with the low-FODMAP diet is, of course, patient adherence,” Koo noted.

Thus, he and his colleagues sought to evaluate the effect that an oral enzyme blend that targets three of the five FODMAP groups (fructans, lactose, and galacto-oligosaccharides) would have on IBS symptoms over 4 weeks.

The study included 442 adults with self-reported physician-diagnosed IBS and/or Rome IV criteria who completed baseline and 4-week follow-up assessments. Mean age was 50.3 years, 86% were women, and 46.6% were already following a low-FODMAP diet.

The primary outcome was the change in IBS-SSS, and secondary outcomes included changes in the five IBS-SSS domains from baseline to 4 weeks:

• Pain severity decreased from 50.0 to 38.3 points
• Pain frequency decreased from 5.9 days in the previous 10 days to 3.9 days
• Distension severity decreased from 61.7 to 43.2 points
• Bowel dissatisfaction decreased from 71.2 to 47.2 points
• Life interference decreased from 60.8 to 38.4 points (all comparisons P<0.001)

Of note, the magnitude of response was similar across IBS subtypes.

PROMIS belly pain and bloating T-scores also significantly improved, as did diet satisfaction scores.

Because roughly half of the patients were already on a low-FODMAP diet, Koo and colleagues conducted a sensitivity analysis showing that improvements in IBS-SSS were consistent whether patients were in the personalization phase of the diet at baseline or remained in the same phase between baseline and week 4, with mean reductions of 101.1 and 104.9 points, respectively.

Koo acknowledged that the study had limitations, including a lack of a placebo or comparator group, a short follow-up of 4 weeks, and the potential for selection bias, “as these patients … proactively sought out this product.”

In addition, when Koo was asked about non-responders, he noted that the enzyme blend used in this study did not target polyols or fructose.