Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt
Stopped early
Conditions studied: Renal Transplant
In brief
This is a hypothesis-generating pilot study. The intent is to model the impact of perioperative practices on the intestinal microbiome and possibly associate these conditions with the final microbiome status (e.g., number of resistance genes and diversity associated with perioperative practices and preoperative microbiome status). Participants will include individuals who are having surgery to either receive or donate a kidney. To determine the diversity change of the intestinal microbiota over time, rectal swabs will be collected before surgery and at several time points after surgery, with the last swab collected 30 days after surgery. This pilot study is to obtain preliminary data to support the rationale and design for a subsequent clinical trial. This study is designed to understand the intestinal microbiota diversity in the setting of renal transplant surgery and the clinical significance of antibiotic use and the associated resistome (collection of all antibiotic resistance genes and precursors within a sample).
Key facts
- Study ID
- NCT03043339
- Run by
- Emory University
- People needed
- 3
- Starts
- 2017-10-02
- Expected to finish
- 2019-01-10
- Last updated by the study team
- 2024-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to understand and the willingness to sign a written informed consent document.
- Ability and willingness to comply with study protocol requirements.
- Completed Verbal Screening Form
- Planned kidney donation or planned receipt of a living donor kidney transplant within 28 days from time of written informed consent.
- If performance status is known, a score of any of the following:
- American Society of Anesthesia (ASA) classification of I (a normal healthy patient), II (a patient with mild systemic disease) or III (a patient with severe systemic disease)
- Eastern Cooperative Oncology Group (ECOG) Status Scale grade of 0 (normal activity), 1 (symptoms, but ambulatory) or 2 (in bed <50% of the time)
- Karnofsky Performance Scale (KPS) of 50% (requires considerable assistance and frequent medical care) to 100% (normal, no complaints, no evidence of disease)
- English speaking.
You may not qualify if…
- Any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to:
- Known active intravenous drug or alcohol abuse
- Psychiatric illness
- Social situation
- Planned or actual receipt of a deceased donor kidney transplant.
- Prior kidney transplant that still requires active immunosuppressive treatment or intervention.
- Presence of diverting ileostomy or colostomy.
Where it is running
- The Emory Clinic — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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