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

NCT ID: NCT03877081

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2023-02-04

Brief Summary

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.

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.

Conditions

Acute Kidney Injury; Probiotics; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotics. Intervention patients

This patients will receive 2 doses of oral probiotics a day, for seven days

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: BIOLOGICAL

Administration of oral probiotics with 2 doses a day

Placebo group

This patients will receive 2 doses of oral placebo a day, for seven days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Administration of oral placebo with 2 doses a day

Interventions

Probiotics

Administration of oral probiotics with 2 doses a day

Intervention Type: BIOLOGICAL

Placebo

Administration of oral placebo with 2 doses a day

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Civil de Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Samuel Chavez Iñiguez

MD, Nephrologist, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HCG

Guadalajara, Jalisco, Mexico

Site Status: RECRUITING

Countries

Mexico

Facility Contacts

Jonathan Samuel Chavez

Role: primary

jonarchi_10@hotmail.com

3313299609

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Other Identifiers

AKI and Probiotics

Identifier Type: -

Identifier Source: org_study_id