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

NCT03877081 | Unknown Phase 3 DMC

• 1 other identifier: AKI and Probiotics
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Probiotics; Sepsis

Keywords

Acute kidney injury; Probiotics; Sepsis; Shock

Outcome Measures

Primary Outcomes (1)

• Serum creatinine

  Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention

  7 days

Secondary Outcomes (7)

• Death

  7 days

• Renal replacement therapy

  7 days

• Final creatinine

  7 days

• Urinary output (final)

  7 days

• Shock days

  7 days

Study Arms (2)

Probiotics. Intervention patients

EXPERIMENTAL

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

Biological: Probiotics

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotics BIOLOGICAL

Administration of oral probiotics with 2 doses a day

Probiotics. Intervention patients

Placebo OTHER

Administration of oral placebo with 2 doses a day

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sepsis by SOFA
• Acute kidney injury by KDIGO

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

HCG

Guadalajara, Jalisco, 44240, Mexico

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Acute Kidney Injury; Sepsis; Shock

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Nephrologist, Principal investigator

Model Details: Double blind randomized controlled trial

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: January 4, 2019
• Primary Completion: September 4, 2022
• Study Completion: February 4, 2023
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

ME (1)