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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT03670693
Eligibility Criteria:
Inclusion Criteria:
Non-Fatigued CD Patients:
* Harvey Bradshaw index \<4
* CRP\<5mg/dl or
* Faecal calprotectin \<50ug/g or,
* As evidenced by recent endoscopy or cross-sectional imaging,
* General fatigue and physical fatigue score on the Multiple Fatigue Inventory-20 \<13
* Score of \<3 in the Fatigue questionnaire.
Fatigued CD Patients:
* Harvey Bradshaw index \<4 and,
* CRP\<5mg/dl or,
* Faecal calprotectin \<50ug/g or,
* As evidenced by recent endoscopy or cross-sectional imagining and,
* General fatigue and physical fatigue score on the Multiple Fatigue Inventory-20 \>14
* Score of \>4 in the Fatigue questionnaire.
Inclusion criteria (Healthy volunteer participants)
* 26 Healthy Volunteers 16-75 years old matched for:
* Gender
* Muscle mass
* Physical activity
* General fatigue and physical fatigue score on the Multiple Fatigue Inventory-20 \<7.
All participants should have a good command of both verbal and written English and be able to give informed consent.
Exclusion Criteria:
Exclusion criteria (CD and Healthy volunteer participants)
Potential participants with any of the following criteria will be excluded:
* \>8 on the Hospital Anxiety and Depression score
* Haematological or biochemical abnormalities (e.g. anaemia (haemoglobin \<13g/dl in a male and 12g/dl in a female)
* Renal failure
* Hypokalaemia
* Pregnancy or childbearing in the last 6 months
* Vitamin B complex deficiencies)
* Active or previous prescriptions of corticosteroids in the last 12 weeks
* Overt muscle wasting (defined as 2 standard deviations outside the age-related norm as measured by DEXA)
* Fatigue starting after the onset of thiopurine therapy
* Present arthritis or arthralgia
* Surgical intervention in the last 12 weeks
* Other aetiologies of chronic liver disease, specifically alcohol or drug induced liver disease, autoimmune or viral hepatitis, cholestatic or metabolic/genetic liver disease by specific clinical, biochemical, radiographic and /or histological criteria.
* Significant cardiovascular or respiratory disease
* Thyroid disease
* Current Infection
* Neurological or cognitive impairment
* Significant physical disability
* Pregnancy or breastfeeding. Participants will be informed before the DEXA scan that pregnancy is an exclusion and standard NHS procedures will be followed- pregnancy tests will be available in the female toilets of the Physiology Unit for self-testing)
* Any other conditions in addition to the above that the investigators consider may affect study measurements or safety
* Inability to understand verbal and/or written explanation of the study requirements
* \>5mSv ionizing radiation exposure in the past 12 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT03670693
Study Brief:
Protocol Section:
NCT03670693