Ulcerative colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group: A single daily pill containing 3 grams of mesalazine. Intervention 2: Intervention group: A single daily pill containing 4 grams of mesalazine.
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age >18 years Simple Clinical Colitis Activity Index (SCCAI) <3 Bowel movements =3 per day Absence of blood in stool during the 3 days prior to enrollment Stable dose or no use of 5-ASA (oral, rectal, or combined) for at least 4 weeks prior to enrollment Stable dose or no use of azathioprine, 6-mercaptopurine, or methotrexate for more than 8 weeks History of no more than one relapse in the previous two years
Exclusion criteria
Exclusion criteria: Lack of willingness to continue participation Remission within less than 4 weeks prior to enrollment Intolerance to higher doses of 5-ASA than the current regimen Moderate or severe abdominal tenderness at the time of study entry Pregnancy or lactation Use of oral or rectal corticosteroids within 2 weeks prior to enrollment Use of >3 g/day of 5-ASA (combined oral and rectal) Use of TNF inhibitors within 8 weeks prior to enrollment Receipt of experimental therapies within 8 weeks prior to enrollment Use of cyclosporines within 2 weeks prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is the change in fecal calprotectin concentration (in µg/g) from baseline to the end of the study period. Timepoint: The primary outcome will be measured at two timepoints: Baseline (Week 0): Before the start of the intervention.End of Trial (Week 8): Eight weeks after the initiation of the intervention. Method of measurement: Fecal calprotectin concentration will be measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit on a single stool sample provided by the patient at each designated timepoint. The results will be reported in micrograms per gram (µg/g) of stool.;Dosage of mesalazine. Timepoint: The effect of increasing the dose of mesalazine on the reduction of fecal calprotectin within 30 days after increasing the dose. Method of measurement: To examine the comparative index between the control group and the intervention group, the independent T-test and CHISQUARE test are used at a significance level of 95%. Data analysis is performed using SPSS Version 22 software. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHadi Abdolahi
Esfahan University of Medical Sciences
Outcome results
None listed