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

April 26, 2020 updated by: Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario José E. Gonzalez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Faecal microbiota transplant
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
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.
Placebo Comparator: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creatinine Clearance
Time Frame: 6 months
Arrest CKD progression
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour Urine Protein
Time Frame: 6 months
Arrest CKD progression
6 months
Serum Creatinine
Time Frame: 6 months
Arrest CKD progression
6 months
Hemoglobin
Time Frame: 6 months
Arrest CKD progression
6 months
Hematocrit
Time Frame: 6 months
Arrest CKD progression
6 months
Leukocytes
Time Frame: 6 months
Arrest CKD progression
6 months
Neutrophils
Time Frame: 6 months
Arrest CKD progression
6 months
Platelets
Time Frame: 6 months
Arrest CKD progression
6 months
Glucose
Time Frame: 6 months
Arrest CKD progression
6 months
Urea Nitrogen
Time Frame: 6 months
Arrest CKD progression
6 months
Uric Acid
Time Frame: 6 months
Arrest CKD progression
6 months
Albumin
Time Frame: 6 months
Arrest CKD progression
6 months
Reactive Protein C
Time Frame: 6 months
Arrest CKD progression
6 months
Chlorine
Time Frame: 6 months
Arrest CKD progression
6 months
Sodium
Time Frame: 6 months
Arrest CKD progression
6 months
Potassium
Time Frame: 6 months
Arrest CKD progression
6 months
Phosphorous
Time Frame: 6 months
Arrest CKD progression
6 months
pH Venous Gasometry
Time Frame: 6 months
Arrest CKD progression
6 months
CO2 pressure venous
Time Frame: 6 months
Arrest CKD progression
6 months
Venous Bicarbonate
Time Frame: 6 months
Arrest CKD progression
6 months
Base Excess
Time Frame: 6 months
Arrest CKD progression
6 months
Lactate
Time Frame: 6 months
Arrest CKD progression
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Adrian Camacho-Ortiz, PhD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Actual)

November 7, 2019

Study Completion (Actual)

April 21, 2020

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 26, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IF18-00003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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