{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T10:24:33Z","timestamp":1756895073838},"reference-count":37,"publisher":"Baishideng Publishing Group Inc.","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["World J Gastrointest Pharmacol Ther"],"abstract":"<jats:p>BACKGROUND<\/jats:p>\n          <jats:p>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\u00ae 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.<\/jats:p>\n          <jats:p>AIM<\/jats:p>\n          <jats:p>To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP\u00ae DIRECT treatment in patients with IBS.<\/jats:p>\n          <jats:p>METHODS<\/jats:p>\n          <jats:p>In this prospective, multicenter, open-label trial, 120 patients with IBS received three sticks of GASTRAP\u00ae 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 \u2265 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.<\/jats:p>\n          <jats:p>RESULTS<\/jats:p>\n          <jats:p>Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 \u00b1 2.4 vs  2.9 \u00b1 2.0, P  &lt; 0.0001). Similar improvements were observed for bloating [8.0 \u00b1 1.7 vs  4.7 \u00b1 2.9, P  &lt; 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 \u00b1 2.1 vs  4.4 \u00b1 3.1, P  &lt; 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 \u00b1 2.0 vs  4.6 \u00b1 2.9, P  &lt; 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 \u201cgood\u201d or \u201cvery good\u201d by 93% of patients.<\/jats:p>\n          <jats:p>CONCLUSION<\/jats:p>\n          <jats:p>GASTRAP\u00ae 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.<\/jats:p>","DOI":"10.4292\/wjgpt.v15.i3.90757","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T07:24:49Z","timestamp":1716535489000},"source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP<sup>\u00ae<\/sup> DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study"],"prefix":"10.4292","volume":"15","author":[{"given":"Nathalie","family":"Talbodec","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pauline","family":"Le Roy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peggy","family":"Fournier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benoit","family":"Lesage","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elodie","family":"Lepoutre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fran\u00e7ois","family":"Castex","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean Michel","family":"Godchaux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lionel","family":"Vandeville","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Bismuth","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Lesage","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pauline","family":"Bayart","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Genin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christel","family":"Rousseaux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronique","family":"Maquet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salvatore","family":"Modica","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Desreumaux","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Valibouze","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2060","published-online":{"date-parts":[[2024,5,28]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.1997.84256000.x"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.3111\/13696998.2012.756397"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12532"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.058"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1111\/apt.17356"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001036"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2021-324598"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1093\/jcag\/gwy071"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1007\/s00535-020-01746-z"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2022.04.017"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2022.04.016"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1002\/ueg2.12259"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0b013e328365abd3"},{"key":"B15","unstructured":"Bertram S, Kurland M, Lydick E, Locke GR 3rd, Yawn BP. 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