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Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease

Multicenter randomized controlled trial to study the efficacy of multidonor fecal microbiota transplantation for Crohn's disease - FMT for Crohn's disease (FEMTRAC) study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033127
Enrollment
50
Registered
2018-09-30
Start date
2018-10-01
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

Crohn&#39

Interventions

fecal microbiota transplatation normal saline administration

Sponsors

Fujita Health University School of Medicine Department of Gastroenterology
Lead Sponsor
Shiga University of Medical Science, Kanazawa University, Hyogo College of Medicine Aichi Medical University, Jichi Medical University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with active Crohn's disease (CDAI 150 or more)

Exclusion criteria

Exclusion criteria: 1. past history of allergy to drugs used in this study 2. possible of documented pregnant women 3. patients with fistula, penetration, and perforation except anal fistula

Design outcomes

Primary

MeasureTime frame
Improvement of CDAI score—

Secondary

MeasureTime frame
1. IBDQ 2. modified SESCD 3. hydrogen level in glucose hydrogen breath test 4. urine lactulose mannnitol ratio 5. change in fecal microbiome and metabolome—

Countries

Japan

Contacts

Public ContactNaoki Ohmiya

Fujita Health University School of Medicine Department of Gastroenterology

nohmiya@fujita-hu.ac.jp0562-93-9240

Outcome results

None listed

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