Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection

Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection - FMT first episode CDI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43385

Enrollment

158

Registered

2016-02-22

Start date

2016-01-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Clostridium difficile infection

Interventions

Duodenal infusion of donor feces (provided by the NNDFB), after a 10-day course of vancomycin (250 mg orally q.i.d.) with bowel lavage one day prior to FMT.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Microbiologically confirmed first episode of Clostridium difficile infection > 17 years Risk estimation score >2 by using the prediction model of D'Agostino Sr et al. Patients should be able to give informed consent

Exclusion criteria

Exclusion criteria: Use of antibiotics other than for CDI at the day of inclusion Pregnancy Dysphagia

Design outcomes

Primary

Measure	Time frame
Primary endpoint is cure (no diarrhea) without relapse. Cure is defined as absence of diarrhea; or normalization of the stool pattern with a negative C. difficile test in patients with pre-existent frequent bowel movements. Relapse is defined as a new episode of diarrhea confirmed by a positive stool C. difficile within 10 weeks after the initiation of therapy.	—

Secondary

Measure	Time frame
It is largely unknown which factors contribute to treatment efficacy. The composition of the microbiota may play an important role. We will analyze the microbiota of patients before and after treatment and will apply metagenomics to determine which bacterial species are essential for protection against CDI. The economic evaluation focuses on the cost-effectiveness and cost-utility of FMT and vancomycin with a 6-month time horizon. The analysis will be performed from a societal perspective based on the incremental costs per decrease of CDI recurrence.	—

Measure

Time frame

It is largely unknown which factors contribute to treatment efficacy. The composition of the microbiota may play an important role. We will analyze the microbiota of patients before and after treatment and will apply metagenomics to determine which bacterial species are essential for protection against CDI. The economic evaluation focuses on the cost-effectiveness and cost-utility of FMT and vancomycin with a 6-month time horizon. The analysis will be performed from a societal perspective based on the incremental costs per decrease of CDI recurrence.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)