Ulcerative colitis Inflammatory bowel disease
Conditions
Interventions
The study drug (Purastat) will be applied to the rectum under the lower gastrointestinal endoscope. A total of 3 subjects will be treated once and the safety results will be analyzed. After seeking th
Sponsors
Itoi Yuki
Uraoka Toshio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Ulcerative colitis between the ages of 18 and 85 at the time of enrollment 2) Patients with mild to moderate disease on the Partial Mayo score 3) Patients who understand the contents of the consent document and give free written consent
Exclusion criteria
Exclusion criteria: 1) Those with concurrent infectious or drug-induced enteritis 2) Pregnant or possibly pregnant 3) Those who are breast-feeding 4) Patients with abnormal blood coagulation function 5) Patients with severe organ failure 6) Other patients who are deemed unsuitable for registration by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage improvement from baseline in Mayo endoscopic score at 2, 3, and 4 endoscopies and percentage of remission Improvement: decrease in Mayo endoscopic score from baseline Remission: 0 or 1 in Mayo endoscopic score | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement from baseline and remission rate of the following endpoints after treatment: Clinical severity (partial mayo score) Clinical severity (partial mayo score) Improvement: decrease of at least 1 point from baseline Remission: total of 2 points or less and none of the subscores exceed 1 Pathological severity (NANCY index) Improvement: decrease of at least 1 point from baseline Remission: NANCY index of 0 or 1 Change from baseline in the following endpoints after treatment (difference between pre and post values) :Hb, CRP, LRG | — |
Contacts
Public ContactYuki Itoi
Gunma University Graduate School of Medicine
Outcome results
None listed