This double-blind, randomized, placebo-controlled trial is the largest to date investigating the efficacy and safety of Enterosgel in the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D).

 Key Efficacy Results

The study demonstrated that Enterosgel significantly improved the composite primary endpoint (abdominal pain and stool consistency) compared to placebo.

Stool Consistency: There was more than a 50% reduction in days with loose stool (BSFS 6 or 7) in the Enterosgel group (from 4.4 to 2.1 days in weeks 5–8).

Associated Symptoms: Significant improvement with Enterosgel was also observed across secondary endpoints, including stool frequency, bloating, and urgency, as well as in Quality of Life (QOL) and activity measures. This suggests that, unlike loperamide, Enterosgel can benefit a wide range of IBS-D symptoms, consistent with its proposed mode of action—binding and removing diarrhea-inducing molecules from the gut.

Overall Patient Satisfaction: The proportion of patients reporting adequate relief of symptoms was significantly higher in the treatment group (0.56 in the double-blind phase) compared to the composite response rate. During the follow-up phase, 80.9% of patients reported maintained or increased treatment benefit and chose to continue taking Enterosgel.

 Safety and Design

Enterosgel showed a favorable safety profile with a low percentage of adverse events comparable to placebo. No serious adverse events related to the administration of Enterosgel were recorded.

Limitations of the study include the difficulty of exactly replicating an identical placebo and the flexible (incremental) dosing regimen, which, while mimicking real-world practice, may have prevented patients from taking a sufficient dose to achieve maximal effect.

 Conclusion

The results of this study confirm that Enterosgel is an effective and safe agent for treating the main symptoms of IBS-D, especially debilitating symptoms like urgency. The drug provides improvement in global symptoms and quality of life, representing a valuable alternative among the limited treatment options currently available for this condition.

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