Clostridioides Difficile: Understanding Responses and Treatment Effects

NCT07374094 | Recruiting

• 1 other identifier: CURE-CDI
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Clostridioides difficile infection; Recurrent Clostridioides difficile infection; Fecal microbiota transplantation; Gut microbiota; Microbiome engraftment; Dysbiosis; Microbial metabolites; Intestinal barrier; Immune response; Antibiotic treatment; Observational study

Outcome Measures

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.

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

Secondary Outcomes (8)

• Number of participants with CDI recurrence

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

• Intestinal microbiota diversity

  Baseline and longitudinal follow-up up to 5 years

• Stool short-chain fatty acid concentrations

  Baseline and longitudinal follow-up up to 5 years

• Colonic mucus barrier function

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

• Circulating markers of intestinal barrier function

  Baseline and longitudinal follow-up up to 5 years

Study Arms (2)

Antibiotic treatment

Participants with Clostridioides difficile infection receiving standard antibiotic treatment as part of routine clinical care.

Other: Antibiotic treatment

Fecal microbiota transplantation (FMT)

Participants with Clostridioides difficile infection receiving fecal microbiota transplantation as part of routine clinical care.

Other: Fecal microbiota transplantation (FMT)

Interventions

Antibiotic treatment OTHER

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.

Antibiotic treatment

Fecal microbiota transplantation (FMT) OTHER

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.

Fecal microbiota transplantation (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples, nasopharyngeal swabs, urine samples, peripheral blood mononuclear cells, blood plasma, colonic biopsies

MeSH Terms

Conditions

Clostridium Infections; Dysbiosis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Johan Rasmuson, MD, PhD

  Umeå University, Department of Clinical Microbiology and Umeå University Hospital, Department of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Rasmuson, MD, PhD

CONTACT

0046-907850000; johan.rasmuson@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 28, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2045
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)