Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients

August 24, 2021 updated by: Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara

Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial

Septic acute kidney injury is a condition associated with highly related to inflammatory molecules. Prebiotics and probiotics have shown to improve inflammatory cascade in animal model; In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. There is no current specific treatment, and the therapeutic approach is more orientated to complication management. In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

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
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44240
        • Recruiting
        • HCG
        • Contact:
        • Principal Investigator:
          • Jonathan S Chavez-Iniguez, MD
        • Sub-Investigator:
          • Guillermo Garcia-Garcia, MD

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:

  • Sepsis by SOFA
  • Acute kidney injury by KDIGO

Exclusion Criteria:

  • No presence of sepsis
  • No presence of AKI
  • Age below 18 years
  • Inability or contraindication for oral capsules or probiotics by nasogastric tube

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotics. Intervention patients
This patients will receive 2 doses of oral probiotics a day, for seven days
Biological: Probiotics
Administration of oral probiotics with 2 doses a day
PLACEBO_COMPARATOR: Placebo group
This patients will receive 2 doses of oral placebo a day, for seven days
Other: Placebo
Administration of oral placebo with 2 doses a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum creatinine
Time Frame: 7 days
Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 7 days
Number of defunctions among the subjects
7 days
Renal replacement therapy
Time Frame: 7 days
Number of participants that initiate renal replacement therapy
7 days
Final creatinine
Time Frame: 7 days
Last recorded serum creatinine concentration
7 days
Urinary output (final)
Time Frame: 7 days
Quantification of urinary output in ml/Kg/hour
7 days
Shock days
Time Frame: 7 days
Use of vasopressor therapy during hospitalization
7 days
Recuperation of basal creatinine
Time Frame: 7 days
Serum creatinine reduction to 25% from basal creatinine
7 days
Length of hospitalization
Time Frame: 7 days
Days of hospitalization
7 days

Collaborators and Investigators

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

Sponsor

Hospital Civil de Guadalajara

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)

January 4, 2019

Primary Completion (ANTICIPATED)

September 4, 2022

Study Completion (ANTICIPATED)

February 4, 2023

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (ACTUAL)

March 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKI and Probiotics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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