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Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis

Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis - Study of safety, efficacy and acceptability of fecal transplantation therapy for Clostridium difficile enteritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026874
Enrollment
30
Registered
2017-04-05
Start date
2017-04-05
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

Clostridium difficile enteritis

Interventions

Diluted faeces of relatives within the third parents are once administered into patien&#39
s colon using the lower gastrointestinal endoscope

Sponsors

Osaka City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Clostridium difficile or Clostridium difficile antigen were detected from feces 2) Patients who did not cure Clostridium difficile enteritis with traditional antibiotic therapy or had a high probability of recurrence of Clostridium difficile enteritis 3) Age at the time of obtaining informed consent is greater than or equal to 20 years. 4) Patients who can eat foods orally. 5) Patients who write document consent by their own will after our explain.

Exclusion criteria

Exclusion criteria: 1) Patients who have malignant tumors or serious systemic diseases (central nervous disease, psychiatric disorders) or poor general condition 2) Patients who already have gastrointestinal disease.(i.e. Crohn's disease, intestinal tuberculosis) 3) Patients who have swallowing disorder 4) Patients who have severe liver disease (AST or ALT >=100 IU/L) 5) Patients who have severe kidney disease (serum Cre >= 2.0 mg/dL) 6) Pregnant or lactating women 7) Patients who are judged by doctors as inappropriate as subjects

Design outcomes

Primary

MeasureTime frame
Cure rate of Clostridium difficile enteritis within 6 months Incidence of adverse events due to fecal microbiota transplantation (FMT)

Secondary

MeasureTime frame
Improvement of intestinal microflora before and after fecal microbiota transplantation therapy

Countries

Japan

Contacts

Public ContactYuji Nadatani

Osaka City University Graduate School of Medicine Department of Gastroenterology

dada@med.osaka-cu.ac.jp06-6645-3811

Outcome results

None listed

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