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Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis

Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis - Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046664
Enrollment
20
Registered
2022-01-17
Start date
2019-02-04
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

nutritional guidance (intervention group) control group

Sponsors

Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients had mild active UC (patients with a UCEIS score of 2-4 points, CAI score of 5-6 points, and a distribution of the UCEIS and CAI scores at admission indicating that the patient was not in remission) were enrolled in the study.

Exclusion criteria

Exclusion criteria: Patients undergoing colonoscopy without pretreatment; those with difficulty following nutritional guidance; those with an intestinal obstruction, fistula, history of colorectal surgery, moderate to severe active-phase UC, diverticulitis, or massive colorectal bleeding; and those with anemia or other underlying conditions except UC were excluded.

Design outcomes

Primary

MeasureTime frame
The primary endpoint was clinical remission at 24 weeks.

Secondary

MeasureTime frame
Secondary endpoints were the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores, the clinical activity index (CAI) evaluated based on symptoms, and biomarkers, including the zinc levels, at 12 and 24 weeks.

Countries

Japan

Contacts

Public ContactKazuya Miyaguchi

Saitama Medical University Department of Gastroenterology

kaz.hr77@gmail.com+81-49-276-1667

Outcome results

None listed

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