Clinical trial NCT04361097: Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease
Official title: Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Due to Hypertension
Chronic Kidney Disease Due to Type 2 Diabetes Mellitus
Keywords: chronic kidney disease
fecal microbiota
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double blind, experimental
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Creatinine Clearance
timeFrame: 6 months
Secondary outcomes:
measure: 24-hour Urine Protein
timeFrame: 6 months
measure: Serum Creatinine
timeFrame: 6 months
measure: Hemoglobin
timeFrame: 6 months
measure: Hematocrit
timeFrame: 6 months
measure: Leukocytes
timeFrame: 6 months
measure: Neutrophils
timeFrame: 6 months
measure: Platelets
timeFrame: 6 months
measure: Glucose
timeFrame: 6 months
measure: Urea Nitrogen
timeFrame: 6 months
measure: Uric Acid
timeFrame: 6 months
measure: Albumin
timeFrame: 6 months
measure: Reactive Protein C
timeFrame: 6 months
measure: Chlorine
timeFrame: 6 months
measure: Sodium
timeFrame: 6 months
measure: Potassium
timeFrame: 6 months
measure: Phosphorous
timeFrame: 6 months
measure: pH Venous Gasometry
timeFrame: 6 months
measure: CO2 pressure venous
timeFrame: 6 months
measure: Venous Bicarbonate
timeFrame: 6 months
measure: Base Excess
timeFrame: 6 months
measure: Lactate
timeFrame: 6 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario José E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL
name: Adrian Camacho-Ortiz, PhD
role: PRINCIPAL_INVESTIGATOR
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