Left-sided ulcerative colitis Digestive System Left-sided ulcerative colitis
Conditions
Interventions
Group 1: Patients will receive a two week course of EGF enema
Group 2: Patients will receive a two week course of mesalazine enema
Participants will be randomly assigned into either group and all par
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged above 18 with a definite diagnosis of UC or proctitis 2. Mild-to-moderate disease activity with a UC Disease Activity Index (UC-DAI) score between three and eight
Exclusion criteria
Exclusion criteria: 1. Patients with infectious colitis 2. Colonic inflammation extending proximal to the left colon (i.e. beyond the splenic flexure on sigmoidoscopic examination) 3. Patients receiving oral maintenance therapy with a total daily dose of more than 3 g of mesalazine within 30 days prior to study entry 4. Use of any immunosuppressive agent within 90 days prior to the study 5. Intake of corticosteroids (orally or rectally) within seven days prior to entry 6. Chronic use of non-steroidal anti-inflammatory drugs in seven days prior to inclusion (chronic use defined as drug intake for a minimum of seven consecutive days) 7. Presence of severe renal/hepatic impairment, malignant disease and allergies to salicylates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission at week two as determined by a UC-DAI score of less than two | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Remission at week four as determined by a UC-DAI score of less than two 2. Improvements in UC-DAI score by more than two points from baseline at week two and week four 3. Improvements in Histological-DAI score by more than two points from baseline at week two and week four | — |
Countries
United Kingdom
Outcome results
None listed