drugset / Trial / NCT04210427
Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
NaSingle-groupOpen-labelTreatment
Summary
The investigators will recruit 15 patients with cystic fibrosis 18 years of age and older who present with constipation. The investigators will assess baseline motility symptoms with a survey. Patients will then ingest a SmartPill (trademark) to obtain baseline motility within the GI lumen. All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily. After two weeks of therapy, the patient will repeat the motility survey and again ingest a smart pill to assess the change in motility symptoms while on therapy.
Timeline
- Start
- 2019-12-12
- Primary completion
- 2023-06-06
- Completion
- 2023-06-06
Publications
- Results Corral JE, Dye CW, Mascarenhas MR, Barkin JS, Salathe M, Moshiree B. Is Gastroparesis Found More Frequently in Patients with Cystic Fibrosis? A Systematic Review. Scientifica (Cairo). 2016;2016:2918139. doi: 10.1155/2016/2918139. Epub 2016 May 30.
- Results Hedsund C, Gregersen T, Joensson IM, Olesen HV, Krogh K. Gastrointestinal transit times and motility in patients with cystic fibrosis. Scand J Gastroenterol. 2012 Sep;47(8-9):920-6. doi: 10.3109/00365521.2012.699548. Epub 2012 Jul 2.
- Results Bentur L, Hino B, Shamir R, Elias N, Hartman C, Eshach-Adiv O, Berkowitz D. Impaired gastric myolectrical activity in patients with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):187-91. doi: 10.1016/j.jcf.2006.03.003. Epub 2006 Apr 19.
- Results Dorsey J, Gonska T. Bacterial overgrowth, dysbiosis, inflammation, and dysmotility in the Cystic Fibrosis intestine. J Cyst Fibros. 2017 Nov;16 Suppl 2:S14-S23. doi: 10.1016/j.jcf.2017.07.014.
- Results Schappi MG, Roulet M, Rochat T, Belli DC. Electrogastrography reveals post-prandial gastric dysmotility in children with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2004 Sep;39(3):253-6. doi: 10.1097/00005176-200409000-00005.
- Results Xu RB, Bhuyan RR, Edwards JR. Staged Bentall procedure and extra-anatomical repair of coarctation of aorta. ANZ J Surg. 2016 Apr;86(4):310-1. doi: 10.1111/ans.12666. Epub 2014 May 29. No abstract available.
- Results Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | polyethylene glycol | Other / unclassified | 17 g | Oral |