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

NCT04361097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-04-28

No results posted yet for this study

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

Conditions

  • Chronic Kidney Disease Due to Hypertension
  • Chronic Kidney Disease Due to Type 2 Diabetes Mellitus

Interventions

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.

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.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2019-11-07
Completion
2020-04-21

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361097 on ClinicalTrials.gov