{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:13:43Z","timestamp":1772165623722,"version":"3.50.1"},"reference-count":7,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,12,11]],"date-time":"2023-12-11T00:00:00Z","timestamp":1702252800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,12,11]],"date-time":"2023-12-11T00:00:00Z","timestamp":1702252800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link>\n                      (NCT03328507) on 01\/11\/2017.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12876-023-03069-8","type":"journal-article","created":{"date-parts":[[2023,12,11]],"date-time":"2023-12-11T03:01:52Z","timestamp":1702263712000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A Phase 2 evaluation of a new flavored peg and sulfate solution compared to an over-the-counter laxative, peg and sports drink bowel preparation combination"],"prefix":"10.1186","volume":"23","author":[{"given":"Gregory","family":"Wiener","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Winkle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John D.","family":"McGowan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark vB.","family":"Cleveland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack A.","family":"Di Palma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,12,11]]},"reference":[{"issue":"2","key":"3069_CR1","doi-asserted-by":"publisher","first-page":"305","DOI":"10.14309\/ajg.0000000000000057","volume":"114","author":"P Gu","year":"2019","unstructured":"Gu P, Lew D, Oh SJ, Vipani A, Ko J, Hsu K, Mirakhor E, Pattisapu V, Bullen T, Fuller G, Spiegel BMR, Almario CV. Comparing the real-world effectiveness of competing Colonoscopy preparations: results of a prospective trial. Am J Gastroenterol. 2019;114(2):305\u201314.","journal-title":"Am J Gastroenterol"},{"key":"3069_CR2","doi-asserted-by":"crossref","unstructured":"Vemulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol 2023;57(4):400\u2013403.","DOI":"10.1097\/MCG.0000000000001689"},{"issue":"6","key":"3069_CR3","doi-asserted-by":"publisher","first-page":"610","DOI":"10.1111\/apt.12884","volume":"40","author":"R Matro","year":"2014","unstructured":"Matro R, et al. Randomised clinical trial: polyethylene glycol 3350 with sports drink vs. polyethylene glycol with Electrolyte Solution as Purgatives for Colonoscopy \u2013 the incidence of Hyponatraemia. Aliment Pharmacol Ther. 2014;40(6):610\u201319.","journal-title":"Aliment Pharmacol Ther"},{"key":"3069_CR4","doi-asserted-by":"crossref","unstructured":"Walker M, Bass R, Hague K, Cleveland MV. A Formulation Development Study of BLI4900, a novel flavor enhanced Bowel Preparation for Colonoscopy. Gastrointestinal Endoscopy, Volume 95, Issue 6, AB67.","DOI":"10.1016\/j.gie.2022.04.188"},{"issue":"5","key":"3069_CR5","doi-asserted-by":"publisher","first-page":"582","DOI":"10.1016\/j.cgh.2013.01.017","volume":"11","author":"P Schoenfeld","year":"2013","unstructured":"Schoenfeld P. Safety of MiraLAX\/Gatorade Bowel Preparation has not been established in appropriately-designed studies. Clin Gastroenterol Hepatol. 2013;11(5):582.","journal-title":"Clin Gastroenterol Hepatol"},{"issue":"2","key":"3069_CR6","first-page":"5582","volume":"106","author":"J Lewis","year":"2011","unstructured":"Lewis J, Schoenfeld P. Severe hyponatremia and Miralax-Gatorade Bowel Preparation. Am J Gastro. 2011;106(2):5582\u20133.","journal-title":"Am J Gastro"},{"issue":"2","key":"3069_CR7","doi-asserted-by":"publisher","first-page":"319","DOI":"10.14309\/ajg.0000000000001020","volume":"116","author":"JA Di Palma","year":"2021","unstructured":"Di Palma JA, Bhandari R, Cleveland MV, Mishkin DS, Tesoriero J, Hall S, McGowan J. A safety and efficacy comparison of a New Sulfate-based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116(2):319\u201328.","journal-title":"Am J Gastroenterol"}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-023-03069-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12876-023-03069-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-023-03069-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,11]],"date-time":"2023-12-11T15:11:17Z","timestamp":1702307477000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-023-03069-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,11]]},"references-count":7,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["3069"],"URL":"https:\/\/doi.org\/10.1186\/s12876-023-03069-8","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-3175279\/v1","asserted-by":"object"}]},"ISSN":["1471-230X"],"issn-type":[{"value":"1471-230X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,11]]},"assertion":[{"value":"16 July 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 December 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 December 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All methods were carried out in accordance with relevant guidelines and regulations. The study protocol was approved by WCG IRB (Payallup, WA) and informed consent was obtained from all subjects.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not Applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Dr. Di Palma is a consultant medical director for Braintree Laboratories. Dr. Cleveland is a scientific consultant. Mr. McGowan is a Braintree employee. The other authors have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"433"}}