A Study to Evaluate the Characteristics and Role of Mucosal Microbiome after Treatment of Clostridium-difficile Infection

Overview

About this study

The purpose of this study is to characterize the mucosal microbiome in patients who have recently been treated for Clostridium-difficile Infection (CDI) in comparison to that of control population to determine the effect of the mucosal associated microbiome on outcome of CDI.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria - CDI patients:

  • Adults aged 18 and over
  • Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea who are currently undergoing treatment or have completed treatment within the last 6 months

Exclusion Criteria - CDI patients:

  • Known active pregnancy.
  • Other known active gastrointestinal infectious process.
  • 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.

Patient Inclusion Criteria - Control Population:

  • Adults aged 18 and over.
  • Undergoing clinically indicated colonoscopy for colon cancer screening or colon polyp surveillance purposes in the absence of active GI symptoms.

Patient Exclusion Criteria - Control Population:

  • Known active pregnancy.
  • Prior diagnosis of CDI.
  • Other known active gastrointestinal infectious process.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Purna Kashyap, M.B.B.S.

Open for enrollment

Contact information:

Heather Lekatz CCRP

(507)538-1206

Lekatz.Heather@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467388

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