Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.

Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1. - Randomized controlled trial that evaluate efficacy of therapeutic intervention for ulcerative colitis patients with the Mayo endoscopic score of 1.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031556

Enrollment

220

Registered

2018-03-02

Start date

2018-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

therapeutic intervention group observation group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients were diagnosed as Ulcerative colitis. 2) Mayo Endoscopic score of 1 3) pMayo above 2 and rectal bleeding score of 0 4) Over 16years old and patients to obtain consent for this study.

Exclusion criteria

Exclusion criteria: Patients with colitis except for Ulcerative colitis. Patients with gastrointestinal obstruction. Preoperation patients. Patients with severe infection. Patients with malignancy or history of malignancy. Patients received anti TNF a antibody, tacrolimus or topical therapy. Inappropriate patients by doctor's judgement.

Design outcomes

Primary

Measure	Time frame
disease relapse for 1 year.	—

Secondary

Measure	Time frame
Relationship between fecal calprotectin and relapse rate Relationship between UCEIS and relapse rate Relationship between dosage of 5ASA and relapse rate Contents of additional treatment after relapse Transition of pMayo during the observation period Relationship between adherence and relapse Safety	—

Countries

Japan

Contacts

Public ContactMakoto Naganuma

Keio University Division of Gastroenterology and Hepatology, Department of Internal Medicine

maknaganuma@gmail.com03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026