An interventional study of Faecal microbiota transplant and Placebo in Chronic Kidney Disease Due to Hypertension and Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Treatment
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:
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:
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
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive frozen capsules to be ingested orally constituted of TMF with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
Biological: Faecal microbiota transplant
This group will receive frozen capsules to be ingested orally placebo with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
Biological: Placebo
Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
Creatinine Clearance
Arrest CKD progression
Time frame: 6 months
24-hour Urine Protein
Arrest CKD progression
Time frame: 6 months
Serum Creatinine
Arrest CKD progression
Time frame: 6 months
Hemoglobin
Arrest CKD progression
Time frame: 6 months
Hematocrit
Arrest CKD progression
Time frame: 6 months
Leukocytes
Arrest CKD progression
Time frame: 6 months
Neutrophils
Arrest CKD progression
Time frame: 6 months
Platelets
Arrest CKD progression
Time frame: 6 months
Glucose
Arrest CKD progression
Time frame: 6 months
Urea Nitrogen
Arrest CKD progression
Time frame: 6 months
Uric Acid
Arrest CKD progression
Time frame: 6 months
Albumin
Arrest CKD progression
Time frame: 6 months
Reactive Protein C
Arrest CKD progression
Time frame: 6 months
Chlorine
Arrest CKD progression
Time frame: 6 months
Sodium
Arrest CKD progression
Time frame: 6 months
Potassium
Arrest CKD progression
Time frame: 6 months
Phosphorous
Arrest CKD progression
Time frame: 6 months
pH Venous Gasometry
Arrest CKD progression
Time frame: 6 months
CO2 pressure venous
Arrest CKD progression
Time frame: 6 months
Venous Bicarbonate
Arrest CKD progression
Time frame: 6 months
Base Excess
Arrest CKD progression
Time frame: 6 months
Lactate
Arrest CKD progression
Time frame: 6 months
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Hospital Universitario Dr. Jose E. Gonzalez