Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
Primary Purpose
Heat Stress, Kidney Injury
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic, Lactobacillus
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Heat Stress focused on measuring Heat stress, Probiotic, Kidney Injury, Gut permeability
Eligibility Criteria
Inclusion Criteria:
- Planning to run one of the long-distance races included.
Exclusion Criteria:
- 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).
Sites / Locations
- Occupational and Environmental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily
Inactive substance packaged to be identical to active treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04985292
Brief Title
Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
Official Title
Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 20, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants registered to run in organised half-marathons, marathons and ultramarathons in Southern Sweden will be recruited. They will be asked to abstain from probiotic supplementation (including functional foods with probiotics) for 2 weeks, and then commence a 4-week period of probiotic or placebo supplementation.
At the end of the 4 week treatment period, the participants run the race. Urine samples are taken before and after the race and analysed for kidney injury markers.
Stool samples are taken by participants at the initiation of the treatment period, last stool before the race, and first stool after the race.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress, Kidney Injury
Keywords
Heat stress, Probiotic, Kidney Injury, Gut permeability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive substance packaged to be identical to active treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic, Lactobacillus
Intervention Description
10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Inactive substance packaged to be identical to active treatment
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Planning to run one of the long-distance races included.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erik Hansson, MD
Phone
+46762463407
Email
erik.hansson@amm.gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Jakobsson, MD, PhD
Phone
0766486023
Email
kristina.jakobsson@amm.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Jakobsson, MD, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Occupational and Environmental Medicine
City
Gothenburg
ZIP/Postal Code
40530
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Hansson, MD
Phone
0762463407
Ext
+46
Email
erik.hansson@amm.gu.se
First Name & Middle Initial & Last Name & Degree
Kristina Jakobsson, PhD
Phone
0766486023
Ext
+46
Email
kristina.jakobsson@amm.gu.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
No information that could be used to identify individuals will be shared. Considering the small size of the study and that it will most likely be conducted over multiple small runs, it is unlikely that any information on age and sex of participants could be shared without a risk of revealing the identity of the individual. Data on treatment allocation, biological measurement and questionnaire data without such identifying individual participant information will however be shared.
IPD Sharing 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.
IPD Sharing Access Criteria
Scientifically sound proposal.
Citations:
PubMed Identifier
28363731
Citation
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. Erratum In: Am J Kidney Dis. 2017 Sep;70(3):452.
Results Reference
background
PubMed Identifier
32498242
Citation
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.
Results Reference
background
PubMed Identifier
25880507
Citation
Leon LR, Bouchama A. Heat stroke. Compr Physiol. 2015 Apr;5(2):611-47. doi: 10.1002/cphy.c140017.
Results Reference
background
PubMed Identifier
31336570
Citation
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.
Results Reference
background
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Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
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