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

Hospital Civil de Guadalajara

Status and phase: Unknown; Phase 3

Conditions: Acute Kidney Injury; Probiotics; Sepsis

Treatments: Other: Placebo; Biological: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03877081

AKI and Probiotics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Probiotics. Intervention patients

Experimental group

Description:

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

Treatment:

Biological: Probiotics

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo