Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Efficacy of a Structured Psychoeducational Inflammatory Bowel Disease Group on the Control of Fatigue in an Adult Outpatient Setting for Patients With Objectively Quiescent Disease.
Brief Summary: Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease (IBD), whether it is Crohn's disease (CD) or ulcerative colitis (UC). Sometimes the fatigue may be easily explained by other symptoms or tests which show that the disease is active. For example patients may be anaemic (have a low blood count) which can in itself lead to a feeling of being tired all the time. Treatment of the disease can make some of these patients feel less fatigued.

However, 4 or 5 out of every 10 patients with IBD which is felt to be in remission (ie not active disease) report fatigue. This can have far-reaching implications for patients in their everyday lives, with issues around work or school, close relationships, travel and leisure being profoundly affected. The CCUK funded research on fatigue and IBD, led by Professor Christine Norton and Wladzia Czuber-Dochan at King's College London, has identified fatigue as being a significant issue facing patients and has also highlighted that few doctors offer help and support beyond treating the disease itself when active. This is partly because fatigue itself has been difficult to measure and so any study designed to treat fatigue would be limited by being unable to quantify any improvement in a meaningful way.

Fortunately the King's College group have developed a 'fatigue score' which is a simple questionnaire that is able to quantify the severity of fatigue. The aim of our study is to assess the effect of a structured support and educational programme on the levels of fatigue in patients with inactive IBD who report moderate or severe levels of fatigue. A secondary component of our study is to see if there are any associations between fatigue levels and disease activity or other parameters such as quality of life, anxiety or symptoms of overlapping irritable bowel syndrome.

Patients will be approached in the out-patient or telephone clinics and the study will be explained with written information and any questions will be answered. If they agree to being involved they will be asked to complete the fatigue and a number of other questionnaires in addition to having the standard assessment of symptoms, blood tests and a stool specimen. Patients with active disease will be excluded from the subsequent group interventions but the data they have provided to this point will still be helpful in our understanding of fatigue in IBD. Patients identified as being in remission following the initial assessments will be offered the opportunity to be involved in the next stage of the study. The stool samples will also be analysed for the microbiome ie which bacteria are present as some studies suggest that patients with IBD may have a reduced diversity of bacteria in their intestines.

Half of this group will be randomised to active intervention and half will act as a control group for the rest of the study. The active intervention will involve completion of activity diaries over the following two weeks and then analysis of the diaries and agreement on behaviour changes designed to help fatigue. This will be supported by written information and three, monthly small group sessions to reinforce and support these changes.

At the end of the study all patients will again complete the fatigue and quality of life questionnaires and have their disease activity assessed by symptom scores, blood and stool tests. The baseline results and the final results will be analysed to see if there is any improvement in fatigue in the group undergoing the programme of support and behaviour change.

This is only a small pilot study but if it demonstrates that the intervention is feasible and may help with fatigue then a larger study will be performed to try and confirm our initial findings.

Our ultimate aim is to find a simple intervention to empower patients to deal with the difficult task of living with IBD and the fatigue that this can bring.


Options:
A: Key Inclusion Criteria:

* Moderate to severe Crohn's disease
* Adequate peripheral venous access
* Agree to participate in the required follow-up visits
* Able to complete a diary
* Signed written informed consent document and authorization for use of protected health information

Key Exclusion Criteria:

* Extremely severe Crohn's disease
* Known obstructive symptoms within the past 3 months
* Presence of toxic megacolon
* Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
* Total colectomy, ileostomy, stoma or 100 cm of resected small bowel
* Requiring in-patient hospitalization
* A history of allergic reaction to heparin or heparin-induced thrombocytopenia
* A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
* A history of severe cardiovascular or peripheral arterial diseases
* A history of cerebral vascular diseases
* Liver diseases
* Renal insufficiency
* Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
* Any hypercoagulable disorder
* Known infection with Hepatitis B or C, or HIV
* Severe anemia
* Leukopenia or granulocytopenia
* Evidence of current systemic infection
* Malignancy
* Pregnant, lactating or planning to become pregnant during the course of the investigational study
* Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
B: Inclusion Criteria:

* proven Crohn's disease
* Single or multiple draining perianal fistulas

Exclusion Criteria:

* Abscesses
* Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
* active viral infection
* significate cardiovascular dysfunction
* Pregnancy, Lactation
* Surgical bowel resection to be expected within 6 months
* Positive stool culture for enteric pathogens
* Total parental nutrition
C: Inclusion Criteria:

* Patiets with IBD in clinical and biochemical remission with no other obvious identifiable explanation for their fatigue

Exclusion Criteria:

* Patients with active inflammation based on symptoms, blood tests, or stool calprotectin level will be excluded from the subsequent psychological intervention aspect of the study. Patients unable to give informed consent or who are unable to understand and follow the intervention will be excluded
D: Inclusion Criteria:

* Diagnosis of Crohns Disease for at least 6 weeks
* Moderate to severe disease activity (CDAI \>= 220 and \<=450)
* No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments
* Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of corticosteriod, OR 5-ASA failures, Or Budesonide failures

Exclusion Criteria:

* History of abdominal surgery within the last 6 months
* Have an ostomy or stoma \[An operation to create an opening from an area inside the body to the outside\]
* Are pregnant, nursing, or planning pregnancy (both men and women)
* Serious simultaneous illness that could interfere with study participation
* Use of any investigational drug within 30 days
* Have a concomitant diagnosis or any history of congestive heart failure
* Weigh more than 140 kilograms (or 310 pounds)

Answer: C