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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01140802
Eligibility Criteria:
Inclusion Criteria:
* patients aged ≥18 with a diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology, patients on stable medication and informed consent obtained
Control group:
Healthy controls (non-IBD patients) will comprise ethnicity - matched patients undergoing colonoscopy for polyp or colorectal cancer screening, or rectal bleeding. Controls will be excluded if they have previously been diagnosed with IBD or if they have a first or second degree relative with IBD.
Relatives group:
Relatives of patients will be aged between 16 and 35 years. They will be a first degree relative of a patient. Relatives older than 35 will not be recruited to maximise the chance of including some individuals who will develop IBD in the future. Relatives will be contacted either via the patient or directly by telephone by the investigators. They will be invited to attend for a screening meeting to assess eligibility and to receive the information sheets. They will undergo a flexible sigmoidoscopy/colonoscopy for biopsies once fully consented.
Exclusion Criteria:
* Patient group:
1. current infection with an enteric pathogen,
2. use of antibiotics within the last month,
3. consumption of any probiotic or prebiotic within the last month,
4. imminent need for surgery,
5. requiring hospitalization,
6. pregnancy or lactation,
7. short bowel syndrome
8. previous proctocolectomy
9. significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator,
10. if they have a history of cancer with a disease free state of less than two years
Control and Relative group:
1. previously been diagnosed with IBD
2. they have a first or second degree relative with IBD
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01140802
Study Brief:
Protocol Section:
NCT01140802