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

• Published in: World journal of gastrointestinal oncology 2024-05, Vol.15 (3), p.90757
• Main Authors: Talbodec, Nathalie, Le Roy, Pauline, Fournier, Peggy, Lesage, Benoit, Lepoutre, Elodie, Castex, François, Godchaux, Jean Michel, Vandeville, Lionel, Bismuth, Benjamin, Lesage, Xavier, Bayart, Pauline, Genin, Michael, Rousseaux, Christel, Maquet, Veronique, Modica, Salvatore, Desreumaux, Pierre, Valibouze, Caroline
• Format: Article
• Language: English
• Subjects: Cognitive science; Prospective Study
• ISSN: 2150-5349; 1948-5204; 2150-5349; 1948-5204
• DOI: 10.4292/wjgpt.v15.i3.90757

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. To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP DIRECT treatment in patients with IBS. 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. Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 ± 2.4 2.9 ± 2.0, < 0.0001). Similar improvements were observed for bloating [8.0 ± 1.7 4.7 ± 2.9, < 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 ± 2.1 4.4 ± 3.1, < 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 ± 2.0 4.6 ± 2.9, < 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. 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.