Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT04210427
Eligibility Criteria:
Inclusion Criteria:
* previously diagnosed with CF confirmed with genetic mutations consistent with CF
* greater than 18 years old who chose to participate in the research study
* have symptoms of constipation (constipation will be defined as stool frequency less than three times per week, Bristol stool scale form 1-2 in \>25% of stools, and/or the sensation of incomplete evacuation, manual maneuvers to facilitate stools, and the sensation of blockage)
The patients enrolled are allowed to be on CFTR modulating drugs and/or receiving enteral feeding.
Exclusion Criteria:
* minors (\<18 years old)
* active nicotine use or patients on nicotine replacement
* history of abdominal surgery (surgeries involving gastrointestinal luminal resection) ie small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen. Surgeries such as Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded from this study.
* history of lung transplantation or pancreas transplant
* BMI \>40
* pregnancy (this will be screened via urine pregnancy test)
* incarcerated persons
* patients with DIOS (distal intestinal obstructive syndrome)
* patients with known hypersensitivity to PEG
* persons unable to remain off the contraindicated medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04210427
Study Brief:
Protocol Section:
NCT04210427