Heat StressNCT04985292
Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
A study testing Probiotic, Lactobacillus in people with Heat Stress and Kidney Injury, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Kidney Injury
- What is being tested?
- Probiotic, Lactobacillus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planning to run one of the long-distance races included.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heat Stress, Kidney Injury
- Being tested
- Probiotic, Lactobacillus, Placebo
- Keywords
- Heat stress, Probiotic, Kidney Injury, Gut permeability
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic, LactobacillusDietary supplement
10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily
PlaceboDietary supplement
Inactive substance packaged to be identical to active treatment
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily Receives: Dietary Supplement: Probiotic, Lactobacillus |
| Placebo | Placebo comparator | Inactive substance packaged to be identical to active treatment Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heat StressStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Jakobsson, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985292
- Sponsor's protocol ID
- 2021-01332
- Status last verified
- Apr 2024
- First submitted
- 10 Jun 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28363731Hansson 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.
PubMed 32498242Leon LR, Bouchama A. Heat stroke. Compr Physiol. 2015 Apr;5(2):611-47. doi: 10.1002/cphy.c140017.
PubMed 25880507Vaisberg 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.
PubMed 31336570
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
- ClinicalTrials.gov ID
- NCT04985292
- Acronym / sponsor ID
- 2021-01332
- Conditions
- Heat Stress, Kidney Injury
- Keywords
- Heat stress, Probiotic, Kidney Injury, Gut permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic, Lactobacillus10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInactive substance packaged to be identical to active treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planning to run one of the long-distance races included.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic, Lactobacillus10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily | Dietary supplement | Probiotic |
| PlaceboInactive substance packaged to be identical to active treatment | Dietary supplement | Placebo |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 28363731Mansour 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.
- Background: PubMed 32498242Hansson 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.
- Background: PubMed 25880507Leon LR, Bouchama A. Heat stroke. Compr Physiol. 2015 Apr;5(2):611-47. doi: 10.1002/cphy.c140017.
- Background: PubMed 31336570Vaisberg 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Jakobsson, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic, Lactobacillus in people with Heat Stress and Kidney Injury, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985292, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.