Chronic Kidney Disease Due to Type 2 Diabetes Mellitus Clinical Trial
Official title:
Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease
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
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
E.- Population in study:
1. -Inclusion criteria: Being diagnosed with CKD and creatinine clearance less than 60
mL/minute secondary hypertension and/or diabetes, older than 18 years.
2. - Exclusion Criteria: Malignancies whose last treatment has been less than 5 years, he
is receiving antibiotics for any reason during the month prior to enrollment, having
received probiotics in the last 3 months, it has been diagnosed with Clostridium
difficile infection in the last year, it has been previously subjected to TMF ,
exacerbations of submitting ERC during the 3 months prior or present at the time of
enrollment.
3. -Criteria for elimination: Failure to comply in the structured patient monitoring,
nondelivery of stool samples at set times, the patient decides to no longer participate
in the study.
F.- Desing Description: After being selected and randomized patients who meet the criteria
for inclusion and exclusion, they are assigned to a group to start treatment TMF (capsules
intestinal microbiota frozen) or a group receive placebo capsules which shall consist of an
excipient harmless to the body (capsules frozen saline), both will be developed in the
service Infectología.
Both groups receive frozen for ingestion orally capsules (comprised of TMF or placebo
according to the randomization) with a frequency of 15 capsules each 12hrs for 4 doses on
days 1, 10 and 30 of the study. Each capsule must be ingested over a period no longer than 1
hour.
measurements characteristic factors of the progression of kidney disease day 0,10, 30, 60,
90, 120 and 180 be made consisting of:
- Proteins in urine 24 hours
- Creatinine clearance 24 hours
- CBC
- serum creatinine
- Urea Nitrogen
- Urea
- Glucose
- Uric acid
- IS
- venous gases
Blood samples were taken by puncture of peripheral vein by laboratory personnel to assess
renal function, urine samples will be collected by the patient at home and transported to the
laboratory, none of these samples will be used for genetic analysis , only samples of faeces
they underwent genomic analysis, collection of stool samples will days 0, 5, 10 30, 90 and
180 (on 10, 30, 90 and 180 with a range of +/- 2 days).
adverse effects questionnaires on days 1, 5, 30 and 60 is performed and quality of life
assessment on days 0, 10, 30, 90 and 180.
Monitoring will face on a weekly basis to register if they have submitted infections, adverse
effects and whether changes have received treatment. Visits will be made in the epidemiology
and the Regional Center for Kidney Diseases University Hospital
;
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