A novel treatment for ulcerative colitis with purastat

Phase 1

Recruiting

• Conditions: lcerative colitis; Inflammatory bowel disease; D003093

• Registration Number: JPRN-jRCTs032230119
• Lead Sponsor: Hashimoto Yu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

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)History of hypersensitivity to peptide or protein preparations6) Other patients who are deemed unsuitable for registration by the physician in charge.
7)Those who are deemed unsuitable for registration by the physician in charge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage improvement from baseline in Mayo endoscopic score at 2, 3, and 4 endoscopies and percentage of remission<br>Improvement: decrease in Mayo endoscopic score from baseline<br>Remission: After allowing for a decrease from baseline. 0 or 1 in Mayo endoscopic score

Secondary Outcome Measures

Name	Time	Method
Improvement from baseline and remission rate of the following endpoints after treatment: Clinical severity (partial mayo score) <br>Clinical severity (partial mayo score) <br>Improvement: decrease of at least 1 point from baseline<br>Remission: total of 2 points or less and none of the subscores exceed 1<br>Pathological severity (NANCY index)<br>Improvement: decrease of at least 1 point from baseline<br>Remission:After allowing for a decrease from baseline. NANCY index of 0 or 1<br><br>Change from baseline in the following endpoints after treatment (difference between pre and post values)<br>:Hb, CRP, LRG