Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP ® DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study.

Background: Irritable bowel syndrome (IBS), defined according to the Rome IV diagnostic criteria, is a chronic functional gastrointestinal disorder characterized by recurrent abdominal pain related to altered bowel habits. First-line recommended treatments are limited to combining drugs targeting predominant symptoms, particularly pain (antispasmodics), constipation (laxatives), and diarrhea (loperamide), yielding only a limited therapeutic gain. GASTRAP ^® DIRECT is a class IIa medical formulation composed of a combination of chitin-glucan and simethicone indicated for the symptomatic treatment of gas-related gastrointestinal disorders by combining different mechanisms of action.
Aim: To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP ^® DIRECT treatment in patients with IBS.
Methods: In this prospective, multicenter, open-label trial, 120 patients with IBS received three sticks of GASTRAP ^® DIRECT (1.5 g/d of chitin-glucan and 0.75 mg/d of simethicone) per day for 4 weeks. The primary endpoint was the responder rate, defined as the number of patients whose abdominal pain score decreased by ≥ 30% from baseline to week (W) 4. The analysis was performed using the per-protocol set. Cardinal symptoms, impact of global symptoms on daily life, change in stool consistency, and improvement in defecatory disorders were evaluated.
Results: Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 ± 2.4 vs 2.9 ± 2.0, P < 0.0001). Similar improvements were observed for bloating [8.0 ± 1.7 vs 4.7 ± 2.9, P < 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 ± 2.1 vs 4.4 ± 3.1, P < 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 ± 2.0 vs 4.6 ± 2.9, P < 0.0001; 54% (95%CI: 44-64) responders]. Stool consistency improved in most patients (90% and 57% for patients with liquid and hard stools, respectively). Overall, 42% of patients with defecatory disorders reported very much/considerable improvements by W2. No severe adverse event occurred, and tolerability was rated "good" or "very good" by 93% of patients.
Conclusion: GASTRAP ^® DIRECT is safe and well tolerated, alleviating IBS symptoms rapidly in 2 weeks. This open-label study suggests that the combination of chitin-glucan and simethicone could be beneficial in patients with IBS.
Competing Interests: Conflict-of-interest statement: Desreumaux P reports receiving personal fees from Abbvie, Abbott, Amgen, Biocodex, Biofortis, Biogen, Biokuris, Ferring, Fresenius, Janssen, Kitozyme, Lesaffre, MSD, Norgine, Pfizer, Sandoz, Shire, Takeda, Tillotts, and UCB outside the submitted work. Dr. Desreumaux has a patent (WO2009103884) issued. Veronique Maquet is a product development manager at Kitozyme. Salvatore Modica is chief operating officer at Biokuris, a spin-off company of Kitozyme. Christel Rousseaux reports other from Biotech Companies, outside the submitted work. The other authors declare no conflicts of interest.
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