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Clostridioides Difficile: Understanding Responses and Treatment Effects

NCT07374094 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-28

No results posted yet for this study

Summary

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.

Conditions

  • Clostridioides Difficile Infection

Interventions

OTHER

Antibiotic treatment

Standard antibiotic treatment for Clostridioides difficile infection administered as part of routine clinical care, according to clinical guidelines. Treatment selection and duration are determined by the treating physician.

OTHER

Fecal microbiota transplantation (FMT)

Fecal microbiota transplantation administered as part of routine clinical care for Clostridioides difficile infection. The route of administration is determined by clinical practice and physician decision.

Sponsors & Collaborators

  • Region Västerbotten

    collaborator OTHER_GOV

  • Umeå University

    lead OTHER

Principal Investigators

  • Johan Rasmuson, MD, PhD · Umeå University, Department of Clinical Microbiology and Umeå University Hospital, Department of Infectious Diseases

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2040-12-31
Completion
2045-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374094 on ClinicalTrials.gov