Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?

NCT04985292 | Completed

• 1 other identifier: 2021-01332
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heat stress; Probiotic; Kidney Injury; Gut permeability

Outcome Measures

Primary Outcomes (1)

• Urine tubular kidney injury marker (Kidney Injury Molecule 1 (KIM-1), monocyte chemotactic protein 1 (MCP-1), Insulin Growth Factor Binding Protein 7 (IGFBP-7)) composite variable aggregated using structural equations modelling.

  Tubular injury markers measured in urine (e.g. KIM-1, MCP-1, IGFBP-7) combined using structural equations modelling and then combined over the 24 hour post-run period by calculating the area under the curve of this composite outcome variable in the 24 hours after the run. Exact list of markers to be determined based on budget available after sample collection is completed.

  From before the run to after the run (estimated run times 2-24 hours), morning urine after run, and 24 hours after the run finish. These time point are combined to one main outcome by calculating the area under the curve.

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Probiotic, Lactobacillus

Placebo

PLACEBO COMPARATOR

Inactive substance packaged to be identical to active treatment

Dietary Supplement: Placebo

Interventions

Probiotic, Lactobacillus DIETARY_SUPPLEMENT

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

Probiotic

Placebo DIETARY_SUPPLEMENT

Inactive substance packaged to be identical to active treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planning to run one of the long-distance races included.

You may not qualify if:

• Not having run at least 21 km previously,
• smoking,
• living too far away from the study area,
• unwilling to abstain from probiotic supplementation during treatment period,
• unwilling to abstain from NSAIDs or gut-permeability lowering supplements before the run,
• regular use of prescribed drugs (including hormonal contraceptives).

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Occupational and Environmental Medicine

Gothenburg, 40530, Sweden

Location

Related Publications (4)

• Mansour SG, Verma G, Pata RW, Martin TG, Perazella MA, Parikh CR. Kidney Injury and Repair Biomarkers in Marathon Runners. Am J Kidney Dis. 2017 Aug;70(2):252-261. doi: 10.1053/j.ajkd.2017.01.045. Epub 2017 Mar 28.

  PMID: 28363731 BACKGROUND

• Hansson E, Glaser J, Jakobsson K, Weiss I, Wesseling C, Lucas RAI, Wei JLK, Ekstrom U, Wijkstrom J, Bodin T, Johnson RJ, Wegman DH. Pathophysiological Mechanisms by which Heat Stress Potentially Induces Kidney Inflammation and Chronic Kidney Disease in Sugarcane Workers. Nutrients. 2020 Jun 2;12(6):1639. doi: 10.3390/nu12061639.

  PMID: 32498242 BACKGROUND

• Leon LR, Bouchama A. Heat stroke. Compr Physiol. 2015 Apr;5(2):611-47. doi: 10.1002/cphy.c140017.

  PMID: 25880507 BACKGROUND

• Vaisberg M, Paixao V, Almeida EB, Santos JMB, Foster R, Rossi M, Pithon-Curi TC, Gorjao R, Momesso CM, Andrade MS, Araujo JR, Garcia MC, Cohen M, Perez EC, Santos-Dias A, Vieira RP, Bachi ALL. Daily Intake of Fermented Milk Containing Lactobacillus casei Shirota (Lcs) Modulates Systemic and Upper Airways Immune/Inflammatory Responses in Marathon Runners. Nutrients. 2019 Jul 22;11(7):1678. doi: 10.3390/nu11071678.

  PMID: 31336570 BACKGROUND

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Probiotics; Lacteol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kristina Jakobsson, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator will be provided with numbered boxes containing study products with identical probiotic and placebo capsules. The numbers have been generated using a block randomization (investigator blinded to length of block). Participants in each of the race will be allocated to receive one of the study product boxes depending on 1. Race order (all participants in the first race receive study product before any participant in the second race), and 2. Time of recruitment into study. There is no care provider in this study of healthy individuals.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before each run (each study participant may only be included in one run) approximately half runners are randomized to receive a probiotic supplement and the other half to receive placebo

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: August 2, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the researchers have reported on the pre-specified research questions or otherwise have decided to make the data publicly available before this. This may be in approximately 2023-2024. We will keep the records for five years.
• Access Criteria: Scientifically sound proposal.

Locations

SE (1)