Copyright
©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP® DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study
Nathalie Talbodec, Pauline Le Roy, Peggy Fournier, Benoit Lesage, Elodie Lepoutre, François Castex, Jean Michel Godchaux, Lionel Vandeville, Benjamin Bismuth, Xavier Lesage, Pauline Bayart, Michael Genin, Christel Rousseaux, Veronique Maquet, Salvatore Modica, Pierre Desreumaux, Caroline Valibouze
Nathalie Talbodec, Peggy Fournier, Benoit Lesage, Elodie Lepoutre, Lionel Vandeville, Benjamin Bismuth, Xavier Lesage, Pauline Bayart, Department of Gastroenterology, Hôpital privé Le Bois, Lille 59000, France
Pauline Le Roy, François Castex, Jean Michel Godchaux, Department of Gastroenterology, Hôpital privé de Villeneuve d’Ascq, Villeneuve d’Ascq 59650, France
Michael Genin, Univ. Lille, CHU Lille, ULR 2694–METRICS, Évaluation des Technologies de Santé et des Pratiques Médicales, Lille 59000, France
Christel Rousseaux, Development of Intestinal Biotech, 1 Avenue Oscar Lambret, Lille 59045, France
Veronique Maquet, KitoZyme SA, Parc Industriel des hauts Sarts Zone 2, Rue de Milmort, Herstal 4040, Belgium
Salvatore Modica, BiOkuris A, Parc Industriel des hauts Sarts Zone 2, Rue de Milmort, Herstal 4040, Belgium
Pierre Desreumaux, Department of Hepato-Gastroenterology, Lille University Hospital, Lille 59000, France
Pierre Desreumaux, Caroline Valibouze, U1286-INFINITE, Institute for Translational Research in Inflammation, Univ. Lille, Inserm, CHU Lille, Lille 59000, France
Caroline Valibouze, Department of Digestive Surgery and Transplantation, Lille University Hospital, Lille 59037, France
Author contributions: Desreumaux P and Valibouze C designed the study; Talbodec N, Le Roy P, Fournier P, Lesage B, Lepoutre E, Castex F, Godchaux JM, Vandeville L, Bismuth B, Lesage X, Bayart P, and Desreumaux P included patients with irritable bowel syndrome; Genin M supervised the statistical analysis; all authors interpreted the data; Valibouze C and Desreumaux P drafted the article; All authors critically reviewed the manuscript and approved the final version for submission. Intestinal Biotech Development supervised study coordination, data collection, and analysis.
Institutional review board statement: This study was approved by the Ethics Committee Sud-Est VI of Clermont-Ferrand (France) (Ref. ID-RCB: 2019-A03202-55) and was performed in accordance with the International Conference on Harmonization of Good Clinical Practice and the ethical principles of the Declaration of Helsinki.
Informed consent statement: A patient information form and a request by the gastroenterologist for non-opposition to the study were obtained from all participants.
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.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/licenses/by-nc/4.0/ Corresponding author: Caroline Valibouze, MD, PhD, Department of Digestive Surgery and Transplantation, Lille University Hospital, Rue Michel Polonowski, Lille 59037, France. caroline.valibouze@chu-lille.fr
Received: January 25, 2024
Revised: March 19, 2024
Accepted: May 8, 2024
Published online: May 28, 2024
Processing time: 122 Days and 9.9 Hours
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.
Core Tip: Irritable bowel syndrome is a common functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits. Treatment options are limited and often inadequate, which leads to dissatisfaction among patients receiving standard medical care. Our study showed that 4 weeks of daily treatment with GASTRAP® DIRECT, a class IIa medical formulation containing a combination of chitin-glucan and simethicone, is well tolerated and rapidly effective in reducing abdominal pain, bloating, abdominal distension, and flatulence with an improvement of stool consistency and defecatory disorders.
