{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T11:27:33Z","timestamp":1780486053051,"version":"3.54.1"},"reference-count":20,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Irritable bowel syndrome with diarrhoea (IBS-D) is a frequent problem associated with a significant socioeconomic implication. Increased gut permeability is an important pathophysiological mechanism. A medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape-seed extract, and xylo-oligosaccharides (XOS) has proven restoration of intestinal barrier function. Our objective was to evaluate the efficacy and safety of treatment with the medical device XG\u2009+\u2009PPT\u2009+\u2009XOS (XG-PPT-XOS) in adult patients with IBS-D in a clinical setting for 6\u2009months. <\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods:<\/jats:title><jats:p> This was a multicentre, open-label, prospective, observational study conducted to evaluate long-term safety and efficacy of XG-PPT-XOS. IBS-D adult patients (Rome IV criteria) were included and received two tablets twice daily for 6\u2009months. IBS Symptom Severity Score (IBS-SSS) and bowel habit were registered at baseline and monthly, until the end of follow up. Efficacy was evaluated by comparison of mean scores at each time point. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> 50 patients were included, of which 19 completed the 6\u2009months. IBS-SSS score decreased from 312.2\u2009\u00b1\u200982.2 to 213.6\u2009\u00b1\u2009109.9 ( p\u2009&lt;\u20090.0001) at 1\u2009month and 192.0\u2009\u00b1\u2009108.9 at the last visit completed; diarrhoea score decreased from 45.6\u2009\u00b1\u200917.9 to 25.7\u2009\u00b1\u200917.7 and 25.3\u2009\u00b1\u200917.2 at 1\u2009month and at the last visit completed, respectively. Pain score decreased from 107.8\u2009\u00b1\u200949.9 at baseline to 73.2\u2009\u00b1\u200957.3 ( p\u2009&lt;\u20090.0001) at 1\u2009month and bloating score from 56.4\u2009\u00b1\u200928.8 at baseline to 42.8\u2009\u00b1\u200932.6 ( p\u2009&lt;\u20090.001) at 1\u2009month, reaching 62.4\u2009\u00b1\u200956.0 and 40.4\u2009\u00b1\u200934.3, respectively, at the last visit completed. Adverse effects were mild and mostly not related to treatment. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Treating IBS-D patients with XG-PPT-XOS is effective and safe in the long term within a clinical setting, improving all IBS-D symptoms from the first month of treatment and showing a sustained response over the term of therapy. <\/jats:p><\/jats:sec>","DOI":"10.1177\/17562848211020570","type":"journal-article","created":{"date-parts":[[2021,5,31]],"date-time":"2021-05-31T06:48:23Z","timestamp":1622443703000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Long-term safety and efficacy study of a medical device containing xyloglucan, pea protein reticulated with tannins and xylo-oligosaccharides, in patients with diarrhoea-predominant irritable bowel syndrome"],"prefix":"10.1177","volume":"14","author":[{"given":"Constanza Ciriza","family":"de los Rios","sequence":"first","affiliation":[{"name":"Servicio de Aparato Digestivo, Instituto de Investigaci\u00f3n Sanitaria San Carlos (IdISSC), Madrid, Spain"},{"name":"Servicio de Aparato Digestivo, Hospital 12 de Octubre, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blanca Serrano","family":"Falc\u00f3n","sequence":"additional","affiliation":[{"name":"Servicio de Aparato Digestivo, Instituto de Investigaci\u00f3n Sanitaria San Carlos (IdISSC), Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Arguelles-Arias","sequence":"additional","affiliation":[{"name":"Servicio de Aparato Digestivo, Universidad de Sevilla, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esperanza","family":"P\u00e9rez","sequence":"additional","affiliation":[{"name":"Servicio de Aparato Digestivo, Hospital Reina Sof\u00eda C\u00f3rdoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Teruel","sequence":"additional","affiliation":[{"name":"Servicio de Aparato Digestivo, Hospital Ramon y Cajal, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Geijo","sequence":"additional","affiliation":[{"name":"Servicio de Aparato Digestivo, Instituto de Investigaci\u00f3n Biom\u00e9dica de Salamanca (IBSAL), Salamanca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5060-7105","authenticated-orcid":false,"given":"Enrique","family":"Rey","sequence":"additional","affiliation":[{"name":"Servicio de Aparato Digestivo, Hospital Cl\u00ednico San Carlos, Universidad Complutense, Instituto de Investigaci\u00f3n Sanitaria San Carlos (IdISSC), Ciudad Universitaria s\/n, Madrid 28040, 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