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Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis

Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis - Efficacy of Intensive Granulocyte and Monocyte Apheresis in Patients with Pouchitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010207
Enrollment
20
Registered
2013-03-11
Start date
2013-03-11
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

Pouchitis

Interventions

Patients to receive 10 GMA sessions at a frequency of 2 sessions per consecutive week

Sponsors

Faculty of Medicine, University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with a current episode of active pouchitis defined as having a pouchitis disease activity index of > 7 after IPAA for UC as confirmed by endoscopy and histology. 2.Patients who have endoscopically detectable lesion. 3.Patients with pouchitis refractory to antibiotics including metronidazole, and ciprofloxacin.

Exclusion criteria

Exclusion criteria: 1.Patients whose granulocyte number is under 2,000/mm3 2.Patients who have or is suspected severe infections.

Design outcomes

Primary

MeasureTime frame
Remission rate (PDAI<7)

Secondary

MeasureTime frame
1. Reduction of fecal markers (calprotectin, lactoferrin), C-reactive protein (CRP), and white blood cell count (WBC). 2. Improvement of endoscopic index reflecting healing of pouchitis lesions. 3. Reduction of the PDAI score 4. Correlation of fecal markers with the PDAI score

Countries

Japan

Contacts

Public ContactToshiaki Watanabe, M.D., Ph.D.

Faculty of Medicine, University of Tokyo Surgery

toshwatanabe@yahoo.co.jp03-5800-8653

Outcome results

None listed

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