Propionyl-L-Carnitine in Ulcerative Colitis

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.