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:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01538251
Eligibility Criteria:
Inclusion Criteria:
* Have read the Information for the Patient and signed the Informed Consent Form.
* Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically and histologically.
* Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1.
* Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
* If female, not pregnant or nursing. For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug and utilization of an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication.
Exclusion Criteria:
* Crohn's disease and indeterminate colitis.
* Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
* Use of systemic antibiotics in the last 10 days preceding the screening.
* Use of systemic Nonsteroidal anti-inflammatory drugs on a repeat basis in the last 10 days preceding the screening.
* Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study.
* Use of immunosuppressants or biological agents within the last 6 weeks preceding the screening.
* Treatment with L-carnitine or its esters derivatives within the last 3 months.
* Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile).
* Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator.
* History of colon resection.
* Diverticulitis, symptomatic diverticulosis.
* Active peptic ulcer disease.
* Proctitis (extent of inflammation \<15 cm from the anus).
* Bleeding disorders
* Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening.
* Active or chronic infection(s) or malignancies.
* Known hypersensitivity to the active ingredient and excipients of the study drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01538251
Study Brief:
Protocol Section:
NCT01538251