Clostridioides Difficile: Understanding Responses and Treatment Effects

Recruiting now

Conditions studied: Clostridioides Difficile Infection

In brief

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.

Key facts

Study ID

NCT07374094

Run by

Umeå University

People needed

200

Starts

2026-01-26

Expected to finish

2045-12-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Willing to participate in protocol-driven follow-up for up to 5 years

You may not qualify if…

• Age below 18 years
• Inability to provide written informed consent

Where it is running

• Umeå University Hospital — Umeå, Sweden (enrolling)

Full record on ClinicalTrials.gov

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