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 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT01865695
Eligibility Criteria:
Inclusion Criteria:
* patients with coeliac disease and having chronic diarrhoea (\>3 loose/ liquid motions a day for more than 4 weeks)
* Patients with a low faecal elastase (\<200 ug/g),
* Patients aged 16 years or over
* Patient able to give written consent to participate
* Patient not currently on Creon
Exclusion Criteria:
* Patients with normal faecal elastase (\> 201ug/g),
* Patients under the age of 16
* Patients allergic to pork or any pig product (advice from the drug manufacturer)
* Patients that are pregnant or are breast-feeding
* Patients taking alternative medication that could affect bowel frequency
* Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial
* Patients who are unable to speak or understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01865695
Study Brief:
Protocol Section:
NCT01865695