A Study to Evaluate the Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridium Difficile Infection
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005222
NCT ID: NCT04679324
Sponsor Protocol Number: 19-005222
About this study
The purpose of this study is to characterize mucosal and luminal microbiome in patients diagnosed with Clostridium difficile infection (CDI), at the time of diagnosis and after treatment, to determine the effect of mucosa associated microbiome on outcome of CDI and the effect of antibiotic treatment on mucosa associated microbiome
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. Contact the study team to discuss study eligibility and potential 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 active pregnancy.
- Prior diagnosis of C. difficile infection within 2 months of this diagnosis.
- 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Purna Kashyap, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available