Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Creatinine Clearance
Study Overview
Brief Summary
What the investigators want to achieve with the protocol is to identify the impact of intestinal microbiota transplantation on the progression of chronic kidney disease.
Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD Methodological design: Experimental, prospective, double-blind. Inclusion criteria: Being diagnosed with CKD and creatinine clearance less than 60 mL/minute secondary hypertension and/or diabetes and older than 18 years
Detailed Description
What the investigators want to achieve with the protocol is to identify that impact has transplantation intestinal microbiota on the progression of chronic kidney disease
A.-Hypothesis: Modification of intestinal microbioma of CKD patients by TMF decrease the progression of CKD.
B.-Specific objectives: Evaluate whether decreases TMF markers of inflammation in patients with CKD after being treated with TMF, evaluate the behavior in CKD progression markers in patients undergoing TMF, evaluate the change in bowel microbioma CKD patients before and after undergoing TMF.
C.-Methodological design: Experimental, prospective, double-blind.
D.-Type of study: Controlled clinical trial
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Third party makes the aleatorization
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be diagnosed with CKD and creatinine clearance less than 60 ml / minute secondary to hypertension and / or diabetes.
- •Age over 18 years
Exclusion Criteria
- •Malignant neoplasms whose last treatment was less than 5 years
- •Having received antibiotics for any reason during the month prior to enrollment
- •Have received probiotics in the last 3 months
- •Have been diagnosed with Clostridium difficile infection in the last year
- •Have been previously submitted to TMF
- •Having presented ERC exacerbations during the 3 months prior or present at the time of enrollment
Outcomes
Primary Outcomes
Creatinine Clearance
Time Frame: 6 months
Arrest CKD progression
Secondary Outcomes
- Phosphorous(6 months)
- Neutrophils(6 months)
- Serum Creatinine(6 months)
- Hematocrit(6 months)
- Leukocytes(6 months)
- Uric Acid(6 months)
- 24-hour Urine Protein(6 months)
- Urea Nitrogen(6 months)
- Chlorine(6 months)
- pH Venous Gasometry(6 months)
- CO2 pressure venous(6 months)
- Venous Bicarbonate(6 months)
- Platelets(6 months)
- Albumin(6 months)
- Potassium(6 months)
- Lactate(6 months)
- Hemoglobin(6 months)
- Glucose(6 months)
- Reactive Protein C(6 months)
- Sodium(6 months)
- Base Excess(6 months)
Investigators
Dr. Adrian Camacho-Ortiz
MD
Hospital Universitario Dr. Jose E. Gonzalez