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:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT01975259
Eligibility Criteria:
Inclusion Criteria:
* Cystic fibrosis as diagnosed by EITHER Cystic fibrosis transmembrane conductance regulator (CFTR) mutation on genotyping OR Positive sweat test (Chloride ≥60mmol/L after pilocarpine iontophoresis) AND Clinical features in keeping with a diagnosis of Cystic Fibrosis
* Clinically stable for at least 4 weeks without inpatient or outpatient treatment for an infective exacerbation - including antibiotics (other than long-term prophylactic therapy) or steroids
Exclusion Criteria:
* Active Pregnancy or \<12 months Post-partum
* Clinically unstable patients
* Patients on long-term steroids
* Patients with known gastroparesis or previous surgery to the gastrointestinal tract (including vagotomy)
* History of organ transplant or planned organ transplant awaited
* Non-CF related diabetes (e.g. Type 1 or 2 Diabetes Mellitus)
* Active malignancy
* Clinically significant derangements in haematological or biochemical indices
* Clinical symptoms of malabsorption (frequent bowel motions/passing of undigested foodstuffs or steatorrhoea)
* Known difficult venous access
* Use of bile acid sequestrants in the previous 4 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
50 Years
Study:
NCT01975259
Study Brief:
Protocol Section:
NCT01975259