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Examination of the effects of prebiotic administration on the intestinal flora of patients with active ulcerative colitis

Examination of the effects of prebiotic administration on the intestinal flora of patients with active ulcerative colitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041240163
Enrollment
40
Registered
2025-01-08
Start date
2025-01-08
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

active ulcerative colitis

Interventions

Assign patients to either kestose plus agaro-oligosaccharides administration group or assign patients to placebo (maltose) administration group

Sponsors

Hirayama Yutaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding. 2. Patients aged 18 at the time of consent. 3. Patients with active ulcerative colitis requiring intensified treatment.

Exclusion criteria

Exclusion criteria: Patients who are judged to be inappropriate by the investigator and the investigator. When it is determined that the continuation of the study drug is not desirable due to the occurrence of an adverse event. If a research subject withdraws consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
:Evaluation of the intestinal microbiota :Changes in Clinical Symptoms(Mayo score, Rachmilewitz clinical activity index, Lichtiger index) :Changes in endoscopic findings (UCEIS and MES), histopathological evaluation

Secondary

MeasureTime frame
:Blood, urine and faeces tests (CBC/general biochemistry, urine biochemistry, faecal calprotectin, inflammatory response markers such as CRP and LRG) :

Contacts

Public ContactYutaka Hirayama

Fujita Health University Hospital

yutaka.hirayama@fujita-hu.ac.jp+81-562932324

Outcome results

None listed

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