Fecal Microbiota Transplantation as a Therapeutic Strategy in the Progression of Chronic Kidney Disease

Hospital Universitario Dr. Jose E. Gonzalez

Status: Completed

Conditions: Chronic Kidney Disease Due to Type 2 Diabetes Mellitus; Chronic Kidney Disease Due to Hypertension

Treatments: Biological: Faecal microbiota transplant; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04361097

IF18-00003

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Faecal microbiota transplant

Experimental group

Description:

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.

Treatment:

Biological: Faecal microbiota transplant

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo