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Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?

NCT04985292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-04-16

No results posted yet for this study

Summary

Severe heat strain arising from intense physical work under climate conditions that does not allow sufficient heat dissipation may lead to heat stroke. This severe conditions is hypothesized to be secondary to increased gut permeability and leakage of bacterial toxins across the gut membrane, stimulating a systematic inflammatory response and associated organ injury. Repeated such sub-clinical increases in gut permeability has been suggested to contribute to the high burden of chronic kidney disease among heat-stressed workers. Many marathon runners experience a transient increase in kidney injury biomarkers while running. Probiotics have been studied as a way to decrease gut permeability and reduce systemic inflammation in many settings, including in athletes . However, no study has measured renal outcomes among workers or athletes performing strenuous activity. This is of interest as it could test the hypothesis that gut-induced inflammation is a driver of kidney injury during heat stress, and could point to a possible intervention to add on to efforts to relieve heat strain.

In the present study, recreational or professional runners will be randomized to take a probiotic supplement or placebo during a 4 week period preceding a strenuous physical exercise (minimum 21 km run). Urine samples will be taken before and after the run, and analyzed for markers of renal injury and inflammation.

Conditions

  • Heat Stress
  • Kidney Injury

Interventions

DIETARY_SUPPLEMENT

Probiotic, Lactobacillus

10\^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily

DIETARY_SUPPLEMENT

Placebo

Inactive substance packaged to be identical to active treatment

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Kristina Jakobsson, MD, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Sweden

Study Locations

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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 NCT04985292 on ClinicalTrials.gov