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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06810167
Eligibility Criteria:
Inclusion Criteria:
1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
2. Meeting criteria for CFrC
Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior:
* Straining in at least 25% of defecations
* Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)
* Sensation of incomplete evacuation more than 25% of defecations
* Sensation of anorectal obstruction/blockage more than 25% of defecations
* Manual disimpaction/manipulation of pelvic floor to facilitate more than 25% of defecations
* Fewer than 3 spontaneous bowel movements weekly (change in stool frequency)
* Loose stools rarely present without the use of laxatives
3. Willingness to avoid major dietary or lifestyle changes during study.
Exclusion Criteria:
1. Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is to be allowed)
2. Inability to discontinue standing bowel regimen (including fiber, stool softener, as well as either osmotic or stimulant laxative, pro-kinetic serotonergic agents, or other therapy) 2-weeks prior to study drug initiation (with ability to use osmotic laxative therapy as rescue therapy only).
3. Severe CFrC as determined by study team
4. Prior tenapanor usage
5. Hospitalization within 4-weeks prior to study initiation.
6. DIOS within 4-weeks prior to study initiation.
7. Other known/suspected mechanical obstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06810167
Study Brief:
Protocol Section:
NCT06810167