Please select the eligibility criteria that correspond to the clinical trial below.
Title: EVALUATION OF THE PILLCAM™ COLON CAPSULE ENDOSCOPY (PCCE) IN PEDIATRIC ULCERATIVE COLITIS
Brief Summary: This prospective pilot study of 30 pediatric subjects, that are indicated for standard colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy.

This study aims

1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.
2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.


Options:
A: ELIGIBILITY Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Inclusion criteria:

Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:

* diagnosis of UC made at least 3 months before the enrolment;
* subject was referred for standard colonoscopy and endoscopic follow-up in Ulcerative colitis
* signed informed consent. Exclusion criteria

The presence of any of the following will exclude a subject from study enrollment:

* Subject has dysphagia
* Subject has renal insufficiency
* Subject is known or suspected structuring CD.
* Subject has a cardiac pacemaker or other implanted electro medical devices.
* Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
* Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
B: Inclusion Criteria (main):

* Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
* Established or new diagnosis
* Disease activity at baseline: Clinical Activity Index (CAI) \>4 and Endoscopic Index (EI) \>= 4

Exclusion Criteria (main):

* Crohn's disease
* Toxic megacolon
* Present or past colorectal cancer
* Symptomatic gastrointestinal disease
* Serious secondary disease(s)
* Baseline stool positive for germs causing bowel disease
* Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
* Current relapse occurred under maintenance treatment with \>2g/day mesalazine
* Serum creatinine \>= 1.2x upper limit of normal (ULN) and creatinine clearance \< 60 ml/min per 1.73 m2
* Serum transaminase (ALT and/or AST), and/or alkaline phosphatase \>= 2x ULN
C: Inclusion Criteria:

* Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
* Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
* Subjects on the following medications;

  1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
  2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
  3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
  4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Exclusion Criteria:

* Anti-TNF therapy within 8 weeks before study drug administration
* Contraindication to colonoscopy or sigmoidoscopy
* Primary or secondary immunodeficiency
* Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
* History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
* Evidence of acute or chronic infection
* Clinically significant disease requiring medication
D: Inclusion Criteria:

* Have read the Information for the Patient and signed the Informed Consent Form.
* Age comprised between 18 and 75 included.
* If female, not pregnant or nursing.
* For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 1 month from the last dose of drug.
* Availability of a pancolonoscopy and histology both confirming the diagnosis of active ulcerative colitis.
* Disease Activity Index comprised between 3 and 10, inclusive, (mild to moderate ulcerative colitis).
* On one of the following treatments for ulcerative colitis prior to baseline visit:

  1. Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine therapy for greater than or equal to 4 weeks prior to baseline assessments.
  2. Stable background mercaptopurine or azathioprine for greater than or equal to 12 weeks prior to baseline assessments.

Exclusion Criteria:

* First diagnosis of ulcerative colitis.
* Crohn's disease.
* Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
* Use of antibiotics in the last 10 days preceding the screening.
* Use of NSAID's in the last 10 days preceding the screening.
* Use of probiotics in the last 10 days preceding the screening
* Positive stool culture (when performed, according to Investigator's judgment, to assess possible parasitologic infection(s)).
* Significantly impaired liver, renal, pulmonary or cardiovascular function.
* History of colon resection.
* Diverticulitis.
* Diagnosis of proctitis
* Stable rectally administered therapy in the last 10 days.
* Active or chronic infection(s).
* Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study.
* Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance.

Answer: A