Clostridioides Difficile: Understanding Responses and Treatment Effects

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University

About this trial

The goal of this observational study is to learn how different treatments for Clostridioides difficile infection (CDI) work, and which biological mechanisms are involved in recovery. The study will compare standard antibiotic treatment and fecal microbiota transplantation (FMT).

The main questions it aims to answer are:

* How do antibiotic treatment and FMT affect treatment outcome in CDI? * How does the gut microbiota change during and after treatment? * Which microbial and metabolic factors are associated with recovery or treatment failure? * How does treatment affect the intestinal barrier, immune response, and patient-reported quality of life?

Participants with CDI will receive treatment as part of routine clinical care, either antibiotics or FMT. Researchers will follow participants over time and collect biological samples to study treatment effects.

Participants will:

* Provide stool samples during the acute infection and during follow-up * Have treatment outcomes assessed at 2 and 8 weeks * Be followed for up to 5 years to study long-term effects * Provide blood and urine samples during follow-up * Provide nasal samples to study potential microbiota changes at distant body sites * Complete questionnaires on symptoms and health-related quality of life * In a subgroup, undergo repeated sigmoid biopsies to study intestinal mucosal healing

The results are expected to increase understanding of how FMT and antibiotics lead to recovery in CDI and may support improved and more targeted future treatments.

Eligibility criteria

Qualifiers

Adults aged 18 years or older

Symptomatic, microbiologically verified Clostridioides difficile infection

Receiving inpatient or outpatient care at Umeå University Hospital

Able and willing to provide written informed consent

Disqualifiers

Age below 18 years

Inability to provide written informed consent

Trial design

Treatments tested in this trial

  • Antibiotic treatment
  • Fecal microbiota transplantation (FMT)

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Umeå University

Lead sponsor

Region Västerbotten

Collaborator