SmartPill Motility System & PillCam Patency Capsule for Cystic Fibrosis
This trial is testing a new way to measure constipation in patients with cystic fibrosis, and whether a common constipation medication is effective.
- Cystic Fibrosis Gastrointestinal Disease
1 Primary · 0 Secondary · Reporting Duration: Change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy
1 Treatment Group
Intervention with polyethylene glycol & SmartPill
1 of 1
15 Total Participants · 1 Treatment Group
Primary Treatment: SmartPill Motility System & PillCam Patency Capsule · No Placebo Group · Phase 4
Who is running the clinical trial?
Age 18 - 40 · All Participants · 4 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Xu, Robert B., Ritwick R. Bhuyan, and James R. M. Edwards. 2014. “Staged Bentall Procedure and Extra-anatomical Repair of Coarctation of Aorta”. ANZ Journal of Surgery. Wiley. doi:10.1111/ans.12666.
- Palsson, Olafur S., William E. Whitehead, Miranda A.L. van Tilburg, Lin Chang, William Chey, Michael D. Crowell, Laurie Keefer, et al.. 2016. “Development and Validation of the Rome IV Diagnostic Questionnaire for Adults”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2016.02.014.
- Bentur, Lea, Bayan Hino, Raanan Shamir, Nael Elias, Corina Hartman, Orly Eshach-Adiv, and Drora Berkowitz. 2006. “Impaired Gastric Myolectrical Activity in Patients with Cystic Fibrosis”. Journal of Cystic Fibrosis. Elsevier BV. doi:10.1016/j.jcf.2006.03.003.
- Dorsey, Jill, and Tanja Gonska. 2017. “Bacterial Overgrowth, Dysbiosis, Inflammation, and Dysmotility in the Cystic Fibrosis Intestine”. Journal of Cystic Fibrosis. Elsevier BV. doi:10.1016/j.jcf.2017.07.014.
- Corral, Juan E., Corey W. Dye, Maria R. Mascarenhas, Jamie S. Barkin, Matthias Salathe, and Baharak Moshiree. 2016. “Is Gastroparesis Found More Frequently in Patients with Cystic Fibrosis? A Systematic Review”. Scientifica. Hindawi Limited. doi:10.1155/2016/2918139.
- Hedsund, Caroline, Tine Gregersen, Iben Moeller Joensson, Hanne Vebert Olesen, and Klaus Krogh. 2012. “Gastrointestinal Transit Times and Motility in Patients with Cystic Fibrosis”. Scandinavian Journal of Gastroenterology. Informa UK Limited. doi:10.3109/00365521.2012.699548.
- Schäppi, Michela G., Michel Roulet, Thierry Rochat, and Dominique C. Belli. 2004. “Electrogastrography Reveals Post-prandial Gastric Dysmotility in Children with Cystic Fibrosis”. Journal of Pediatric Gastroenterology and Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005176-200409000-00005.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Dhiren Patel, MD 2019. "Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210427.
Frequently Asked Questions
What type of participant would be most advantageous for this clinical investigation?
"This fibrosis research study is looking to enrol 15 patients, aged 18-40, who suffer from cystic fibrosis. To qualify for the trial they must have a confirmed diagnosis of CF via genetic mutations as well as demonstrate symptoms such as infrequent bowel movements or difficulty evacuating their bowels. Participants are allowed to be on CFTR modulators and/or receiving enteral feeding during the course of the trial." - Anonymous Online Contributor
Could you please provide an overview of the prior research done with SmartPill Motility System & PillCam Patency Capsule?
"Currently, 16 medical experiments are underway related to the SmartPill Motility System & PillCam Patency Capsule. Not a single one is in Phase 3 at this time; however, these trials span 25 locations with most of them being based in Tempe, Arizona." - Anonymous Online Contributor
Has the FDA given authorization to use SmartPill Motility System & PillCam Patency Capsule?
"The SmartPill Motility System & PillCam Patency Capsule is rated a 3 on our safety scale, as the trial has been approved and entered Phase 4." - Anonymous Online Contributor
Does this research initiative accept participants aged 30 or older?
"This clinical trial requires participants to be between 18 and 40 years old. There are 110 trials available for minors, while those over 65 can participate in 432 studies." - Anonymous Online Contributor
Is enrollment still available to participants for this trial?
"The trial, posted on December 12th 2019 and last revised June 8th 2022, is in need of participants as per information available on clinicaltrials.gov." - Anonymous Online Contributor
To what ailments does the SmartPill Motility System & PillCam Patency Capsule offer relief?
"SmartPill Motility System & PillCam Patency Capsule are frequently used to ameliorate dyschezia. Additionally, this technology has been effective at managing the symptoms of exophthalmos, constipation, and colonoscopy." - Anonymous Online Contributor
What is the recruitment quota for this clinical evaluation?
"Affirmative. According to clinicaltrials.gov, this experiment is in the process of seeking participants and was first shared on December 12th 2019 with a last update made June 8th 2022. 15 candidates are being sought between two distinct sites." - Anonymous Online Contributor