Actively Recruiting

Age: 18Years +
All Genders
ID07374094

Studies of Treatment Effects, Host-Pathogen Responses, and Therapeutic Mechanisms in Clostridioides Difficile Infection

Led by Umeå University · Updated on 2026-01-28

200

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

U

Umeå University

Lead Sponsor

R

Region Västerbotten

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how different treatments for Clostridioides difficile infection (CDI) work and the biological processes involved in recovery. This observational study compares standard antibiotic treatment and fecal microbiota transplantation (FMT) to understand how these therapies affect treatment outcomes, gut microbiota changes, intestinal barriers, immune responses, and patient quality of life. The study follows adult patients with verified CDI receiving routine care, aiming to uncover factors linked to recovery or treatment failure over time. Participants receive either antibiotics or FMT as part of their usual medical care, with treatment choices made by their doctors. Biological samples such as stool, blood, urine, and nasal swabs are collected during the acute infection and follow-up periods, with more frequent stool sampling after FMT to monitor early changes. A subgroup may undergo repeated lower colon biopsies to study mucosal healing. The study includes long-term follow-up for up to five years to evaluate ongoing effects and treatment responses. During the study, participants will provide various biological samples and complete questionnaires on symptoms and quality of life. Researchers will assess treatment outcomes at 2 and 8 weeks, including sustained cure and recurrence, and monitor microbiota diversity, metabolic profiles, intestinal barrier function, and immune markers. The study aims to deepen understanding of how antibiotics and FMT lead to recovery in CDI and support future improvements in microbiota-based treatments.

CONDITIONS

Brief Title

Clostridioides Difficile: Understanding Responses and Treatment Effects

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 5 years

Participants who undergo routine care for Clostridioides difficile infection are observed. Biological samples including stool, blood, urine, and nasopharyngeal swabs are collected during the acute infection and at defined follow-up time points to assess microbiota, immune responses, and intestinal barrier function.

Assessments at baseline, 2 weeks, 8 weeks, and periodic follow-up visits for up to 5 years

Long-term Monitoring

Duration - Up to 5 years

Participants continue to be followed longitudinally with periodic assessments of clinical outcomes, microbiota composition, immune markers, and quality of life for up to 5 years after treatment initiation.

Periodic visits over 5 years depending on clinical course

Trial Site Locations

Total: 1 location

1

Umeå University Hospital

Umeå, Sweden

Actively Recruiting

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Research Team

J

Johan Rasmuson, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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