Safety of rectal administration of a biocompatible synthetic peptide, PuraStat in Active Distal Ulcerative Colitis and Proctitis

JRCT ID: jRCTs012240012

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ulcerative colitis
• Date of first enrollment: 01/05/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Purestat is applied transendoscopically to the inflamed colonic mucosa

Outcome(s)

• Primary Outcome: Percentage of patients with a Mayo score (bloody stools) reduction of at least 1 point from baseline after 28 days of PureStat administration

Secondary Outcome

(1) Improvement rate of Numeric Rating Scale related to bowel urgency of bowel movement after 28 days after treatment with PureStat
(2) Improvement rate of Partial Mayo score after 28 days after treatment with PureStat
(3) Improvement rate of hematochezia in Mayo score after 14 days of treatment with PureStat
(4) Improvement rate of Numeric Rating Scale related to bowel urgency of bowel movement after 14 days of treatment with PureStat
(5) Improvement rate of NRS related to blood stool score after 14 days of treatment with PureStat
(6) Change in endoscopic scores (MES, UCEIS) before and after PureStat administration
(7) Change in Mayo score before and after PureStat administration
(8) Changes in pathological findings before and after treatment with PureStat
(9) Changes in gene expression of inflammatory cytokines in the rectal mucosa before and after treatment with PureStat

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with proctitis or left-sided colitis whose lesions are localized in the sigmoid colon to rectum
(2) Patients with hematochezia
(3) Patients who are 20 years of age or older at the time of consent
(4) Patients who have given a full explanation of their participation in this study and have given their voluntary written consent.

Exclude criteria

(1) Patients with UC of the extensive colitis type
(2) Patients after total colorectal resection
(3) Patients with undetermined diagnosis
(4) Patients with bleeding tendency
(5) Patients taking antithrombotic drugs
(6) Patients who are deemed inappropriate as research subjects by the investigator
(7) Patients with a history of hypersensitivity to peptide or protein preparations
(8) Pregnant or breast feeding patients
(9) Patients who are participating in other clinical studies, including clinical trials.
(10) Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Nakase Hiroshi Nakase
• Source(s) of Monetary Support: 3D MATRIX MEDICAL TECHNOLOGY