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
Abstract Background 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 sulf...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-12-01
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| Series: | BMC Gastroenterology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12876-023-03069-8 |
| _version_ | 1797388309405630464 |
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| author | Gregory Wiener Peter Winkle John D. McGowan Mark vB. Cleveland Jack A. Di Palma |
| author_facet | Gregory Wiener Peter Winkle John D. McGowan Mark vB. Cleveland Jack A. Di Palma |
| author_sort | Gregory Wiener |
| collection | DOAJ |
| description | Abstract Background 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. Methods 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. Results 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. Conclusion 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 www.clinicaltrials.gov (NCT03328507) on 01/11/2017. |
| first_indexed | 2024-03-08T22:38:55Z |
| format | Article |
| id | doaj.art-f25ac4fc03a2493f866c7157ea0cf3ea |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-03-08T22:38:55Z |
| publishDate | 2023-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Gastroenterology |
| spelling | doaj.art-f25ac4fc03a2493f866c7157ea0cf3ea2023-12-17T12:19:26ZengBMCBMC Gastroenterology1471-230X2023-12-012311610.1186/s12876-023-03069-8A Phase 2 evaluation of a new flavored peg and sulfate solution compared to an over-the-counter laxative, peg and sports drink bowel preparation combinationGregory Wiener0Peter Winkle1John D. McGowan2Mark vB. Cleveland3Jack A. Di Palma4GW Research, IncCenExel ACT Anaheim, Chula VistaBraintree Laboratories, IncBraintree Laboratories, IncFrederick P. Whiddon College of Medicine, University of South AlabamaAbstract Background 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. Methods 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. Results 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. Conclusion 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 www.clinicaltrials.gov (NCT03328507) on 01/11/2017.https://doi.org/10.1186/s12876-023-03069-8Bowel preprationColonoscopyLaxativeSports drinkPolyethylene glycol |
| spellingShingle | Gregory Wiener Peter Winkle John D. McGowan Mark vB. Cleveland Jack A. Di Palma 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 BMC Gastroenterology Bowel prepration Colonoscopy Laxative Sports drink Polyethylene glycol |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Bowel prepration Colonoscopy Laxative Sports drink Polyethylene glycol |
| url | https://doi.org/10.1186/s12876-023-03069-8 |
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