RunningINFultraNCT06089174
Assessment of the Increased Risk of Infection Following an Ultratrail
A study testing Ultra-trail in people with Running and Immune Deficiency, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Running, Immune Deficiency, Infections
- What is being tested?
- Ultra-trail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteReunion
- Study dates
- 6 Oct 2023to 14 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years
- Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous)
- Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires
- Do not object to the research
Who cannot join
- Do not understand French
- A protected adult (guardianship or curatorship) or under court protection
Trial locations and contacts
1 site in 1 country.
About this study
The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence.
The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.
- Conditions
- Running, Immune Deficiency, Infections
- Being tested
- Ultra-trail
- Keywords
- Immune deficiency, Ultra-running, Infection
- Medical subject headings
- Immunologic Deficiency Syndromes, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-trailOther
Questionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21)
| Study group | Role | What they receive |
|---|---|---|
| Exposed (Runners) | Experimental | Ultra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km Receives: Other: Ultra-trail |
| Non-exposed (companions) | No intervention | Runners' companions not running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased risk of infection
Comparing the incidence of all infectious symptoms in runners taking part in one of the Grand Raid races (exposed subjects) with the incidence of infectious symptoms in those accompanying them on the race.
fever, congestion, stuffy nose, sneezing, shortness of breath, vomiting, diarrhea, headache, sore throat, general fatigue, burning and urinary symptoms, other infectious symptoms; associated with major infections (respiratory, skin, gastrointestinal, urinary, other)
Measured: Day 21
Secondary outcomes (5)
Kinetic of infections' appearance
Kinetics of the onset of infectious symptoms within 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects) and their companions (unexposed subjects). Survival curves over the 3 weeks post-race will be produced.
An on-line questionnaire will be used to collect infectious data.
Measured: Day 21
Risk factors: running distance
Identify if the distance of the race in which the runner participates is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
An on-line questionnaire will be used to collect data related to the race distance.
Measured: Day 21
Risk factors: training volume
Identify if the runner's training volume is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Measured: Day 21
Risk factors: sex of the runner
Identify if sex of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Measured: Day 21
Risk factors: age category
Identify if the age of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start6 Oct 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RunningStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a descriptive cohort study comparing the occurrence of infection between exposed (runners of an ultra-trail) and unexposed subjects (their companions).
- Masking
- None (open label)
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Monnet University, Hôpital Privé de la Loire- Saint Etienne
- Responsible party
- Sponsor
- Investigators
- Nicolas BOUSCAREN, MD, Principal investigator, CHU de la Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089174
- Sponsor's protocol ID
- 2023/CHU/23
- Acronym
- INFultra
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Increased Risk of Infection Following an Ultratrail
- ClinicalTrials.gov ID
- NCT06089174
- Acronym / sponsor ID
- INFultra / 2023/CHU/23
- Conditions
- Running, Immune Deficiency, Infections
- Keywords
- Immune deficiency, Ultra-running, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Jean Monnet University, Hôpital Privé de la Loire- Saint Etienne
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 18 Oct 2023 (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.
The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence.
The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a descriptive cohort study comparing the occurrence of infection between exposed (runners of an ultra-trail) and unexposed subjects (their companions).
| Arm | Type | Receives |
|---|---|---|
| Exposed (Runners) | Experimental | Other: Ultra-trailUltra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km |
| Non-exposed (companions) | No intervention | –Runners' companions not running |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous)
- Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires
- Do not object to the research
Key exclusion criteria (2 listed)
- Do not understand French
- A protected adult (guardianship or curatorship) or under court protection
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 |
|---|---|---|
| Ultra-trailQuestionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21) | Other | Exposed (Runners) |
Primary outcome
Increased risk of infection
Time frame: Day 21
Comparing the incidence of all infectious symptoms in runners taking part in one of the Grand Raid races (exposed subjects) with the incidence of infectious symptoms in those accompanying them on the race. fever, congestion, stuffy nose, sneezing, shortness of breath, vomiting, diarrhea, headache, sore throat, general fatigue, burning and urinary symptoms, other infectious symptoms; associated with major infections (respiratory, skin, gastrointestinal, urinary, other)
5 secondary outcomes
Kinetic of infections' appearance
Time frame: Day 21
Risk factors: running distance
Time frame: Day 21
Risk factors: training volume
Time frame: Day 21
Risk factors: sex of the runner
Time frame: Day 21
Risk factors: age category
Time frame: Day 21
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 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Nicolas BOUSCAREN, MD principal investigator
CHU de la Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-trail in people with Running and Immune Deficiency, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 4 inclusion and 2 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 17 Feb 2026. 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 Reunion. 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. 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?
Increased risk of infection (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.