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OpenTrials
Completed

NCT Number: NCT04675723

The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been treated for C. difficile infection to determine if there are features associated with recurrent disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Patients who have recently been diagnosed with C. difficile infection and completed treatment will be enrolled to undergo evaluation of the colonic mucosa via sigmoid biopsies. Participants will also complete surveys, blood draw and stool collection. Overall goals are to identify whether C. difficile is persisting in the colon mucosa after treated infection, and whether this, and other clinical and microbiome factors may be playing a role in disease recurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 and over
  • Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea

Exclusion criteria

  • Known pregnancy
  • Prior diagnosis of C. difficile infection within 2 months of this diagnosis
  • Other known active gastrointestinal infectious process
  • Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions
  • Vulnerable adults
  • Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

Treatment and study plan

Primary outcomes

  1. Mucosal presence

    Time frame: 1-14 days post C. Difficile treatment

    Identification of C. difficile within the colonic mucosa on stained slides from biopsy samples

  2. Disease recurrence

    Time frame: 8 weeks

    Determination of recurrent C. difficile infection based on symptoms and potential clinical testing

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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