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Clostridioides Difficile: Understanding Responses and Treatment Effects

ConditionClostridioides Difficile Infection
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

This trial does not accept healthy volunteers

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 population

Adult patients with symptomatic, microbiologically verified Clostridioides difficile infection receiving inpatient or outpatient care at Umeå University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Antibiotic treatment

    Other intervention

    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.

  • Fecal microbiota transplantation (FMT)

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Antibiotic treatment1 intervention
Group B: Fecal microbiota transplantation (FMT)1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with sustained cure

Number of participants with sustained cure, defined as resolution of Clostridioides difficile infection symptoms after completion of the current treatment course and no recurrence during the 8-week follow-up period.

Time frame
At follow-up 8 weeks after initiation of the current CDI treatment.

Secondary outcomes

1

Number of participants with CDI recurrence

Number of participants with Clostridioides difficile infection recurrence during the 8-week follow-up period, classified according to established clinical guidelines.

Time frame
At follow-up 8 weeks after initiation of the current CDI treatment
2

Intestinal microbiota diversity

Changes in intestinal microbiota diversity assessed by metagenomic sequencing of stool samples.

Time frame
Baseline and longitudinal follow-up up to 5 years
3

Stool short-chain fatty acid concentrations

Changes in stool short-chain fatty acid concentrations assessed using metabolomic methods.

Time frame
Baseline and longitudinal follow-up up to 5 years
4

Colonic mucus barrier function

Changes in colonic mucus barrier function assessed by ex vivo measurements of mucus growth rate and mucus layer integrity in colonic biopsy samples obtained from a subgroup of participants.

Time frame
Baseline and follow-up assessments up to approximately 8 weeks after initiation of the current CDI treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Region Västerbotten

Collaborator

Source ClinicalTrials.gov
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