Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis

Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis - Randomized controlled trial of the influence on mucosal regulatory T cells and fecal butyric acid by administration of Clostridium butyricum and resistant starch for pediatric ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023885

Enrollment

Registered

2016-09-01

Start date

2016-09-01

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

Clostridium butyricum 3g of once, 3 times a day and resistant starch 10g of once, 2 times a day for 52 weeks. Controls.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pediatric ulcerative colitis patients aged from 8 year old to less than 19 year old with the agreement.

Exclusion criteria

Exclusion criteria: Patients with refusal for informed consent, and judged inappropriate.

Design outcomes

Primary

Measure	Time frame
the frequency of relapse in pediatric ulcerative colitis patients by the administration for 12 months.	—

Secondary

Measure	Time frame
mucosal regulatory T cells and fecal butyric acid by the administration for more than 1 month	—

Countries

Japan

Contacts

Public ContactTakahiro Kudo

juntendo University Hospital Department of Pediatrics and Adolescent Medicine

t-kudo@juntendo.ac.jp0338133111

Outcome results

None listed

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