Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial
Background Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestina...
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| Veröffentlicht in: | United European gastroenterology journal 2019-10, Vol.7 (8), p.1093-1101 |
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| creator | Trifan, Anca Burta, Ovidiu Tiuca, Nicoleta Petrisor, Diana Corina Lenghel, Augustin Santos, Javier |
| description | Background
Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier.
Objective
The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D).
Methods
In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days.
Results
At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; p = 0.0019) presented normal stools (Bristol Stool Form Scale type 3−4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; p = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events.
Conclusion
XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated. |
| doi_str_mv | 10.1177/2050640619862721 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_24P</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6794699</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_2050640619862721</sage_id><sourcerecordid>2310657673</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4840-ad30cf92269ee7d20debacb1587d7379b7729b201340a134e1a20123ee0fa3fa3</originalsourceid><addsrcrecordid>eNqFUV1rFDEUHUSxpfbdJ8mjD47ma5MZH4RatqtQ6It9DneSO21KNlmT2ZbBP9-0WxcVpCHk655z7r05TfOW0Y-Maf2J0wVVkirWd4przl40hw9PrZJMvtyfqTpojku5oXV0neRcvm4OBFOKd0odNr-W4-gt2JlAdKTAiNNM0khWGAraCSIZUybOQ87XCaHdZHRp7SPEific_QRDQDKkOwykzNHltMbP5ITkKldxBd0HYnMqJd1iJjb4WLMFMmUP4U3zaoSa5vhpP2ouz5Y_Tr-15xer76cn562VnaQtOEHt2HOuekTtOHU4gB3YotNOC90PWvN-4JQJSaEuyKBeuECkI4g6j5ovO93NdlijsxinDMFssl9Dnk0Cb_6ORH9trtKtUbqXqu-rwPsngZx-brFMpnZmMQSImLbFcMGoWmilRYXSHfSx6YzjPg2j5sE2869tlfLuz_L2hN8mVUC_A9z5gPOzguZyueJfzyiVglZuu-MWuEJzk7Y51q_-fzH3f1KyEA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2310657673</pqid></control><display><type>article</type><title>Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial</title><source>Wiley Online Library Open Access</source><creator>Trifan, Anca ; Burta, Ovidiu ; Tiuca, Nicoleta ; Petrisor, Diana Corina ; Lenghel, Augustin ; Santos, Javier</creator><creatorcontrib>Trifan, Anca ; Burta, Ovidiu ; Tiuca, Nicoleta ; Petrisor, Diana Corina ; Lenghel, Augustin ; Santos, Javier</creatorcontrib><description>Background
Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier.
Objective
The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D).
Methods
In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days.
Results
At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; p = 0.0019) presented normal stools (Bristol Stool Form Scale type 3−4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; p = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events.
Conclusion
XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.</description><identifier>ISSN: 2050-6406</identifier><identifier>EISSN: 2050-6414</identifier><identifier>DOI: 10.1177/2050640619862721</identifier><identifier>PMID: 31662866</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject><![CDATA[Abdominal Pain - diagnosis ; Abdominal Pain - drug therapy ; Abdominal Pain - etiology ; Adult ; Cross-Over Studies ; Demulcents - administration & dosage ; Demulcents - therapeutic use ; Diarrhea - drug therapy ; Diarrhoea-predominant irritable bowel syndrome ; Double-Blind Method ; Drug Therapy, Combination ; Equipment Design - instrumentation ; Female ; Follow-Up Studies ; Gelsectan ; Glucans - administration & dosage ; Glucans - therapeutic use ; Humans ; Irritable Bowel Syndrome - complications ; Irritable Bowel Syndrome - diagnosis ; Irritable Bowel Syndrome - epidemiology ; Irritable Bowel Syndrome - psychology ; Male ; mucoprotectants ; Oligosaccharides - administration & dosage ; Oligosaccharides - therapeutic use ; Original ; pea protein and tannins ; Pea Proteins - administration & dosage ; Pea Proteins - therapeutic use ; Placebos - administration & dosage ; prebiotics ; Prebiotics - administration & dosage ; Prevalence ; Quality of Life ; Romania - epidemiology ; Safety ; Treatment Outcome ; Xylans - administration & dosage ; Xylans - therapeutic use ; xylo-oligosaccharide ; xyloglucan]]></subject><ispartof>United European gastroenterology journal, 2019-10, Vol.7 (8), p.1093-1101</ispartof><rights>Author(s) 2019</rights><rights>2019 The Authors. UEG Journal published by Wiley Periodicals LLC. on behalf of United European Gastroenterology</rights><rights>Author(s) 2019.</rights><rights>Author(s) 2019 2019 United European Gastroenterology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4840-ad30cf92269ee7d20debacb1587d7379b7729b201340a134e1a20123ee0fa3fa3</citedby><cites>FETCH-LOGICAL-c4840-ad30cf92269ee7d20debacb1587d7379b7729b201340a134e1a20123ee0fa3fa3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6794699/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6794699/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,1411,11541,27901,27902,45550,45551,46027,46451,53766,53768</link.rule.ids><linktorsrc>$$Uhttps://onlinelibrary.wiley.com/doi/abs/10.1177%2F2050640619862721$$EView_record_in_Wiley-Blackwell$$FView_record_in_$$GWiley-Blackwell</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31662866$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Trifan, Anca</creatorcontrib><creatorcontrib>Burta, Ovidiu</creatorcontrib><creatorcontrib>Tiuca, Nicoleta</creatorcontrib><creatorcontrib>Petrisor, Diana Corina</creatorcontrib><creatorcontrib>Lenghel, Augustin</creatorcontrib><creatorcontrib>Santos, Javier</creatorcontrib><title>Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial</title><title>United European gastroenterology journal</title><addtitle>United European Gastroenterol J</addtitle><description>Background
Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier.
Objective
The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D).
Methods
In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days.
Results
At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; p = 0.0019) presented normal stools (Bristol Stool Form Scale type 3−4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; p = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events.
Conclusion
XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.</description><subject>Abdominal Pain - diagnosis</subject><subject>Abdominal Pain - drug therapy</subject><subject>Abdominal Pain - etiology</subject><subject>Adult</subject><subject>Cross-Over Studies</subject><subject>Demulcents - administration & dosage</subject><subject>Demulcents - therapeutic use</subject><subject>Diarrhea - drug therapy</subject><subject>Diarrhoea-predominant irritable bowel syndrome</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Equipment Design - instrumentation</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gelsectan</subject><subject>Glucans - administration & dosage</subject><subject>Glucans - therapeutic use</subject><subject>Humans</subject><subject>Irritable Bowel Syndrome - complications</subject><subject>Irritable Bowel Syndrome - diagnosis</subject><subject>Irritable Bowel Syndrome - epidemiology</subject><subject>Irritable Bowel Syndrome - psychology</subject><subject>Male</subject><subject>mucoprotectants</subject><subject>Oligosaccharides - administration & dosage</subject><subject>Oligosaccharides - therapeutic use</subject><subject>Original</subject><subject>pea protein and tannins</subject><subject>Pea Proteins - administration & dosage</subject><subject>Pea Proteins - therapeutic use</subject><subject>Placebos - administration & dosage</subject><subject>prebiotics</subject><subject>Prebiotics - administration & dosage</subject><subject>Prevalence</subject><subject>Quality of Life</subject><subject>Romania - epidemiology</subject><subject>Safety</subject><subject>Treatment Outcome</subject><subject>Xylans - administration & dosage</subject><subject>Xylans - therapeutic use</subject><subject>xylo-oligosaccharide</subject><subject>xyloglucan</subject><issn>2050-6406</issn><issn>2050-6414</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUV1rFDEUHUSxpfbdJ8mjD47ma5MZH4RatqtQ6It9DneSO21KNlmT2ZbBP9-0WxcVpCHk655z7r05TfOW0Y-Maf2J0wVVkirWd4przl40hw9PrZJMvtyfqTpojku5oXV0neRcvm4OBFOKd0odNr-W4-gt2JlAdKTAiNNM0khWGAraCSIZUybOQ87XCaHdZHRp7SPEific_QRDQDKkOwykzNHltMbP5ITkKldxBd0HYnMqJd1iJjb4WLMFMmUP4U3zaoSa5vhpP2ouz5Y_Tr-15xer76cn562VnaQtOEHt2HOuekTtOHU4gB3YotNOC90PWvN-4JQJSaEuyKBeuECkI4g6j5ovO93NdlijsxinDMFssl9Dnk0Cb_6ORH9trtKtUbqXqu-rwPsngZx-brFMpnZmMQSImLbFcMGoWmilRYXSHfSx6YzjPg2j5sE2869tlfLuz_L2hN8mVUC_A9z5gPOzguZyueJfzyiVglZuu-MWuEJzk7Y51q_-fzH3f1KyEA</recordid><startdate>201910</startdate><enddate>201910</enddate><creator>Trifan, Anca</creator><creator>Burta, Ovidiu</creator><creator>Tiuca, Nicoleta</creator><creator>Petrisor, Diana Corina</creator><creator>Lenghel, Augustin</creator><creator>Santos, Javier</creator><general>SAGE Publications</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201910</creationdate><title>Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial</title><author>Trifan, Anca ; Burta, Ovidiu ; Tiuca, Nicoleta ; Petrisor, Diana Corina ; Lenghel, Augustin ; Santos, Javier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4840-ad30cf92269ee7d20debacb1587d7379b7729b201340a134e1a20123ee0fa3fa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Abdominal Pain - diagnosis</topic><topic>Abdominal Pain - drug therapy</topic><topic>Abdominal Pain - etiology</topic><topic>Adult</topic><topic>Cross-Over Studies</topic><topic>Demulcents - administration & dosage</topic><topic>Demulcents - therapeutic use</topic><topic>Diarrhea - drug therapy</topic><topic>Diarrhoea-predominant irritable bowel syndrome</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Equipment Design - instrumentation</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gelsectan</topic><topic>Glucans - administration & dosage</topic><topic>Glucans - therapeutic use</topic><topic>Humans</topic><topic>Irritable Bowel Syndrome - complications</topic><topic>Irritable Bowel Syndrome - diagnosis</topic><topic>Irritable Bowel Syndrome - epidemiology</topic><topic>Irritable Bowel Syndrome - psychology</topic><topic>Male</topic><topic>mucoprotectants</topic><topic>Oligosaccharides - administration & dosage</topic><topic>Oligosaccharides - therapeutic use</topic><topic>Original</topic><topic>pea protein and tannins</topic><topic>Pea Proteins - administration & dosage</topic><topic>Pea Proteins - therapeutic use</topic><topic>Placebos - administration & dosage</topic><topic>prebiotics</topic><topic>Prebiotics - administration & dosage</topic><topic>Prevalence</topic><topic>Quality of Life</topic><topic>Romania - epidemiology</topic><topic>Safety</topic><topic>Treatment Outcome</topic><topic>Xylans - administration & dosage</topic><topic>Xylans - therapeutic use</topic><topic>xylo-oligosaccharide</topic><topic>xyloglucan</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Trifan, Anca</creatorcontrib><creatorcontrib>Burta, Ovidiu</creatorcontrib><creatorcontrib>Tiuca, Nicoleta</creatorcontrib><creatorcontrib>Petrisor, Diana Corina</creatorcontrib><creatorcontrib>Lenghel, Augustin</creatorcontrib><creatorcontrib>Santos, Javier</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>United European gastroenterology journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Trifan, Anca</au><au>Burta, Ovidiu</au><au>Tiuca, Nicoleta</au><au>Petrisor, Diana Corina</au><au>Lenghel, Augustin</au><au>Santos, Javier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial</atitle><jtitle>United European gastroenterology journal</jtitle><addtitle>United European Gastroenterol J</addtitle><date>2019-10</date><risdate>2019</risdate><volume>7</volume><issue>8</issue><spage>1093</spage><epage>1101</epage><pages>1093-1101</pages><issn>2050-6406</issn><eissn>2050-6414</eissn><abstract>Background
Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier.
Objective
The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D).
Methods
In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days.
Results
At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; p = 0.0019) presented normal stools (Bristol Stool Form Scale type 3−4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; p = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events.
Conclusion
XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>31662866</pmid><doi>10.1177/2050640619862721</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 2050-6406 |
| ispartof | United European gastroenterology journal, 2019-10, Vol.7 (8), p.1093-1101 |
| issn | 2050-6406 2050-6414 |
| language | eng |
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| source | Wiley Online Library Open Access |
| subjects | Abdominal Pain - diagnosis Abdominal Pain - drug therapy Abdominal Pain - etiology Adult Cross-Over Studies Demulcents - administration & dosage Demulcents - therapeutic use Diarrhea - drug therapy Diarrhoea-predominant irritable bowel syndrome Double-Blind Method Drug Therapy, Combination Equipment Design - instrumentation Female Follow-Up Studies Gelsectan Glucans - administration & dosage Glucans - therapeutic use Humans Irritable Bowel Syndrome - complications Irritable Bowel Syndrome - diagnosis Irritable Bowel Syndrome - epidemiology Irritable Bowel Syndrome - psychology Male mucoprotectants Oligosaccharides - administration & dosage Oligosaccharides - therapeutic use Original pea protein and tannins Pea Proteins - administration & dosage Pea Proteins - therapeutic use Placebos - administration & dosage prebiotics Prebiotics - administration & dosage Prevalence Quality of Life Romania - epidemiology Safety Treatment Outcome Xylans - administration & dosage Xylans - therapeutic use xylo-oligosaccharide xyloglucan |
| title | Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial |
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