Treatment of recurrent Clostridium difficile infection with fecal therapy: the FECAL trial (Fecal enema to Eliminate Clostridium difficile Associated Longstanding diarrhea)

Treatment of recurrent Clostridium difficile infection with fecal therapy: the FECAL trial (Fecal enema to Eliminate Clostridium difficile Associated Longstanding diarrhea) - FECAL trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30253

Enrollment

136

Registered

2007-01-23

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bacterial infections chronic diarrhea

Interventions

Interventional therapy comprises standard oral antibiotic vancomycine, bowel lavage with cleanprep, and feces infusions via the gastroscope in the entire gut.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who once have been treated with proper antibiotics for positieve C. difficile associated diarrhee and now presenting with recurrence of diarrhee can be included in our study.

Exclusion criteria

Exclusion criteria: Patients with limited life-expectancy (less than 3 months) are excluded from study participance. Feces donor subjects will be selected form healthy relatives and friends and will be thoroughly screened on contagious diseases in blood and feces.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is response after 3 weeks of initiation of therapy.	—

Secondary

Measure	Time frame
Secondary endpoints are time to cure and time without diarrhea during the observation period of 8 weeks following study inclusion. The study will also include an economic evaluation (based on the secondary outcome measures).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)