ProbioticsNCT06552806
The Effect of a Multi-strain Probiotic on Acclimatization to High Altitude
A study testing SLAB51 in people with Probiotics, run by University of California, San Diego at 2 sites in United States.
Trial summary
The goal of this study is to learn if the probiotic SLAB51 (Sivomixx800®) works to enhance acclimatization to high altitude in humans. The main questions it aims to answer are: Does SLAB51 improve oxygen saturation during high-altitude exposure? Researchers will compare SLAB51 to a placebo (a substance that contains… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotics
- What is being tested?
- SLAB51
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form. Participants must have the cognitive ability to consent to participate in this study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons aged ≥ 18 years old or ≤ 65 years old.
- Women and men will be studied.
- We will recruit healthy participants, in good general health evidenced by medical history.
- Pregnancy test will be done previous to the beginning of the study. No other specific laboratory tests will be performed before the study.
- In the case of participants that can get pregnant, we ask them to use effective contraception at least 1 month previous to the beginning of the first trip, and in between the first and the second trip.
- Ability to take oral medication and be willing to adhere to the SLAB51 regimen.
Who cannot join
- No exclusion criteria based on languages spoken.
- No exclusion will be based on gender, race, socioeconomic status.
- History of cardiovascular or pulmonary disease, including HAPE and HACE.
- Female's menstrual phase and use of birth control pills will be documented, as hormones are reported to influence the control of breathing (Regensteiner et al. 1989). However, women under birth control will not be excluded from the study. Pregnant females will be excluded.
- Current smoker or tobacco use (more than 1 cigarette per day).
- Presence of systemic or local infection.
Show all 13Show fewer
- Patients with history of chronic cardiac, pulmonary, renal, liver, neurological, or psychiatric disease (except controlled mood disorders), i.e., failure to achieve SaO2 > 95% when breathing supplemental oxygen (inspired PO2 = 200-225 mmHg, equivalent to 30% O2 at sea level).
- Cases of acute pancreatitis and acute hypersensitivity to gluten and lactose.
- Immunosuppressed patients.
- Participants with a BMI higher than 35.
- Participants will be asked to answer a survey (STOP-BANG Score for Obstructive Sleep Apnea, https://www.mdcalc.com/calc/3992/stop-bang-score-obstructive-sleep-apnea) to determine self-reported OSA. Patients with a STOP-Bang Score higher equal or higher than 3 will be excluded.
- Use of any medications or agents that might interfere with the physiological measurements, such as ventilation and heart rate, will result in exclusion from our study, such as ibuprofen, anti-hypertensives, benzodiazepines, sleep aids including melatonin, opioids, other narcotics/sedatives and acetazolamide.
- Participants must not have traveled above 2,500 m (8,202 feet) of elevation for 4 weeks prior to the initial baseline measurement at sea level and throughout the duration of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
White Mountain Research Station
Bishop, California, 93514
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: The Effect of a Multi-strain Probiotic SLAB51 (Sivomixx800®) on Acclimatization to High Altitude
The goal of this study is to learn if the probiotic SLAB51 (Sivomixx800®) works to enhance acclimatization to high altitude in humans. The main questions it aims to answer are:
Does SLAB51 improve oxygen saturation during high-altitude exposure? Researchers will compare SLAB51 to a placebo (a substance that contains no probiotic) to see if SLAB51 works to enhance high-altitude acclimatization.
Read more
Participants will:
Take SLAB51 or a placebo three times daily during two separate three-night acclimatization periods at high altitude, spaced at least six weeks apart.
Complete baseline measurements at sea level. Visit the high-altitude Barcroft Station (3,801 m) at the University of California White Mountain Research Center for physiological measurements and assessments.
Undergo assessments including oxygen saturation, ventilation, heart rate, blood pressure, sleep studies, cognitive assessments, exercise capacity, Acute Mountain Sickness scores, and provide blood, fecal, and urine samples for advanced analyses.
Read the detailed description
Individuals will be recruited to participate in a double-blind, placebo controlled, cross-over study receiving placebo or the nutritional supplement probiotic SLAB51 (Sivomixx800®) during exposure to high altitude to test the effects of SLAB51 on high-altitude acclimatization.
Humans face significant physiological detriments when they ascend to high altitude due to hypobaric hypoxia, and physiological changes are crucial for acclimatization to this stressful environment. Currently, there are limited interventions to improve acclimatization to high altitude. The investigators conducting this study will test if the probiotic SLAB51 improves oxygen saturation and mitigates negative outcomes often experienced during acclimatization to high altitude through studies performed at sea level and at the high-altitude Barcroft Station (3,801 m) at the University of California White Mountain Research Center.
Preliminary studies indicate that ingestion of SLAB51 significantly improves oxygenation in humans during physical exercise in simulated altitude within a hypobaric chamber, in a pressurized airplane cabin during commercial flight, in premature born babies, and in COVID-19 patients. Here, the investigators explore whether ingestion of SLAB51 affects acclimatization to high altitude in healthy humans. Physiological measurements include oxygen saturation (O2 Sat or SpO2 during wakefulness and sleep, primary outcomes) as well as ventilation, heart rate, blood pressure, sleep studies, cognitive assessments, exercise capacity, measurement of the Acute Mountain Sickness score, and the collection of blood, fecal, and urine samples to further explored through transcriptomics, methylation, metabolomics, and proteomics. All measurements will be taken in up to 60 participants on two separate occasions separated by at least 6 weeks. Participants will complete all assessments, one baseline measurement obtained at sea level (0 - 300 m) and then twice during three-night acclimatization periods at Barcroft Station (3,801 m). At high altitude, participants will receive a treatment (placebo or SLAB51) upon arrival at Barcroft Station and then three times a day until departure from the high-altitude site. During the second portion of the study approximately six weeks later, participants will complete the same repeat assessments during a second three-night visit at Barcroft Station, where they will receive whichever treatment was not taken during the high-altitude exposure six weeks prior. Both participants and researchers performing the studies will be blinded to the treatment. Upon completion of the study, researchers will compare how participants acclimatized when they received SLAB51 versus when they received the placebo treatment.
- Conditions
- Probiotics
- Being tested
- SLAB51
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLAB51Dietary supplement
Also called Oxxyslab
One dose of SLAB51 is administered after arrival to high altitude, then three times a day approximately every 5 hours upon waking during Days 2 and 3, and a final dose the morning of Day 4 of acclimatization.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | SLAB51 will be administered orally each day during the four days at high altitude. Each dose of SLAB51 consists of one six-gram sachet dissolved in 100 mL of water, containing approximately 800 billion bacteria. Participants will receive, in one of their trips, one dose of SLAB51 after arrival to high altitude, then three times a day approximately every 5 hours upon waking during Days 2 and 3, and a final dose the morning of Day 4 of acclimatization. Receives: Dietary Supplement: SLAB51 |
| Placebo group | Placebo comparator | Placebo will be administered in the other trip, following the same schedule as SLAB51 as described above. Receives: Dietary Supplement: SLAB51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
The effects of treatment group (probiotic or placebo) and timepoint on daytime SpO2 and mean nocturnal SpO2 will be determined by two-way analysis of variance (ANOVA) with a Bonferroni post hoc test.
Measured: At sea level (one day, one night) and all four days and three nights of the study at high altitude
Secondary outcomes (16)
Hypoxic ventilatory response
Changes in ventilation due to the decrease of oxygen saturation (10%) and/or increase in carbon dioxide (5mmHg)
Measured: At sea level (one day) and one day at high altitude
Heart rate
Heart rate measurement
Measured: At sea level (one day, one night) and all four days at high altitude
Heart rate variability
Values of high frequency-low frequency ratio (HF/LF) of volunteers administered with SLAB51
Measured: At sea level (one day, one night) and all four days at high altitude
Blood pressure
Blood pressure measurement
Measured: At sea level (one day, one night) and all four days at high altitude
Sleep oxygen saturation
Oxygen levels during sleep
Measured: At sea level (one night) and all three nights of the study at high altitude
Sleep apnea hypopnea index
Number of times breathing stops and leads to a decrease of 3% oxygen saturation
Measured: At sea level (one night) and all three nights of the study at high altitude
Sleep oxygen desaturation index
How often and how much a person's blood oxygen saturation drops (at least 4%) during sleep
Measured: At sea level (one night) and all three nights of the study at high altitude
Sleep duration
How many hours and minutes a person sleeps during the night
Measured: At sea level (one night) and all three nights of the study at high altitude
Cancellation Pictures cognitive test
A timed, tablet-based test of selective attention and inhibitory control
Measured: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Contrast Sensitivity cognitive test
Measures the ability to distinguish between fine increments of light and dark (contrast)
Measured: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Digits-in-Noise cognitive test
Presents trials of three sequential spoken digits against a broad-band, speech-shaped masker. The outcome measure is the threshold noise tolerance.
Measured: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Spatial Release from Masking cognitive test
Tests the ability to distinguish speech from competing speech using headphones and virtual spatial locations.
Measured: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Trail Making cognitive test
A measure of visual attention and task switching ability with outcome measures of response time and accuracy.
Measured: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Oxygen saturation in submaximal exercise
Measurement of oxygen saturation during the final 30 seconds of submaximal exercise on a stationary bike
Measured: At sea level (one day) and one day at high altitude
Lactate following submaximal exercise
Measurements of lactate following submaximal exercise on a stationary bike
Measured: At sea level (one day) and one day at high altitude
Acute Mountain Sickness Score
Questionnaire to gauge how a person feels at high altitude. It defines AMS as the presence of headaches in addition to three other symptoms, including gastrointestinal symptoms, fatigue/weakness, and dizziness/lightheadedness. Each symptom is appointed a point on a scale from 0 to 3, with 0 being no effect and 3 being severe. A total score of 3 or greater, with the presence of headaches, in a setting of rapid ascent to high altitude, is diagnosed as acute mountain sickness.
Measured: At sea level (one day) and all four days of the study at high altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jun 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measurement double-blind, placebo controlled, cross-over study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatum Simonson, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552806
- Sponsor's protocol ID
- 807971
- Status last verified
- Aug 2024
- First submitted
- 6 Jul 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Although general information of mean and standard error data will be indicated in the graphs used for this project, individual data will be shown in as dots in the exposed graphs, and in tables when this is not possible.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-strain Probiotic SLAB51 (Sivomixx800®) on Acclimatization to High Altitude
- ClinicalTrials.gov ID
- NCT06552806
- Acronym / sponsor ID
- 807971
- Conditions
- Probiotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 Aug 2024 (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 goal of this study is to learn if the probiotic SLAB51 (Sivomixx800®) works to enhance acclimatization to high altitude in humans. The main questions it aims to answer are:
Does SLAB51 improve oxygen saturation during high-altitude exposure? Researchers will compare SLAB51 to a placebo (a substance that contains no probiotic) to see if SLAB51 works to enhance high-altitude acclimatization.
Participants will:
Take SLAB51 or a placebo three times daily during two separate three-night acclimatization periods at high altitude, spaced at least six weeks apart.
Complete baseline measurements at sea level. Visit the high-altitude Barcroft Station (3,801 m) at the University of California White Mountain Research Center for physiological measurements and assessments.
Undergo assessments including oxygen saturation, ventilation, heart rate, blood pressure, sleep studies, cognitive assessments, exercise capacity, Acute Mountain Sickness scores, and provide blood, fecal, and urine samples for advanced analyses.
Detailed description
Individuals will be recruited to participate in a double-blind, placebo controlled, cross-over study receiving placebo or the nutritional supplement probiotic SLAB51 (Sivomixx800®) during exposure to high altitude to test the effects of SLAB51 on high-altitude acclimatization.
Humans face significant physiological detriments when they ascend to high altitude due to hypobaric hypoxia, and physiological changes are crucial for acclimatization to this stressful environment. Currently, there are limited interventions to improve acclimatization to high altitude. The investigators conducting this study will test if the probiotic SLAB51 improves oxygen saturation and mitigates negative outcomes often experienced during acclimatization to high altitude through studies performed at sea level and at the high-altitude Barcroft Station (3,801 m) at the University of California White Mountain Research Center.
Preliminary studies indicate that ingestion of SLAB51 significantly improves oxygenation in humans during physical exercise in simulated altitude within a hypobaric chamber, in a pressurized airplane cabin during commercial flight, in premature born babies, and in COVID-19 patients. Here, the investigators explore whether ingestion of SLAB51 affects acclimatization to high altitude in healthy humans. Physiological measurements include oxygen saturation (O2 Sat or SpO2 during wakefulness and sleep, primary outcomes) as well as ventilation, heart rate, blood pressure, sleep studies, cognitive assessments, exercise capacity, measurement of the Acute Mountain Sickness score, and the collection of blood, fecal, and urine samples to further explored through transcriptomics, methylation, metabolomics, and proteomics. All measurements will be taken in up to 60 participants on two separate occasions separated by at least 6 weeks. Participants will complete all assessments, one baseline measurement obtained at sea level (0 - 300 m) and then twice during three-night acclimatization periods at Barcroft Station (3,801 m). At high altitude, participants will receive a treatment (placebo or SLAB51) upon arrival at Barcroft Station and then three times a day until departure from the high-altitude site. During the second portion of the study approximately six weeks later, participants will complete the same repeat assessments during a second three-night visit at Barcroft Station, where they will receive whichever treatment was not taken during the high-altitude exposure six weeks prior. Both participants and researchers performing the studies will be blinded to the treatment. Upon completion of the study, researchers will compare how participants acclimatized when they received SLAB51 versus when they received the placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Repeated measurement double-blind, placebo controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: SLAB51SLAB51 will be administered orally each day during the four days at high altitude. Each dose of SLAB51 consists of one six-gram sachet dissolved in 100 mL of water, containing approximately 800 billion bacteria. Participants will receive, in one of their trips, one dose of SLAB51 after arrival to high altitude, then three times a day approximately every 5 hours upon waking during Days 2 and 3, and a final dose the morning of Day 4 of acclimatization. |
| Placebo group | Placebo comparator | Dietary Supplement: SLAB51Placebo will be administered in the other trip, following the same schedule as SLAB51 as described above. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form. Participants must have the cognitive ability to consent to participate in this study.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons aged ≥ 18 years old or ≤ 65 years old.
- Women and men will be studied.
- We will recruit healthy participants, in good general health evidenced by medical history.
Key exclusion criteria (13 listed)
- No exclusion criteria based on languages spoken.
- No exclusion will be based on gender, race, socioeconomic status.
- History of cardiovascular or pulmonary disease, including HAPE and HACE.
- Female's menstrual phase and use of birth control pills will be documented, as hormones are reported to influence the control of breathing (Regensteiner et al. 1989). However, women under birth control will not be excluded from the study. Pregnant females will be excluded.
- Current smoker or tobacco use (more than 1 cigarette per day).
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 |
|---|---|---|
| SLAB51Also: OxxyslabOne dose of SLAB51 is administered after arrival to high altitude, then three times a day approximately every 5 hours upon waking during Days 2 and 3, and a final dose the morning of Day 4 of acclimatization. | Dietary supplement | Placebo group, Probiotic group |
Primary outcome
Oxygen saturation
Time frame: At sea level (one day, one night) and all four days and three nights of the study at high altitude
The effects of treatment group (probiotic or placebo) and timepoint on daytime SpO2 and mean nocturnal SpO2 will be determined by two-way analysis of variance (ANOVA) with a Bonferroni post hoc test.
16 secondary outcomes
Hypoxic ventilatory response
Time frame: At sea level (one day) and one day at high altitude
Heart rate
Time frame: At sea level (one day, one night) and all four days at high altitude
Heart rate variability
Time frame: At sea level (one day, one night) and all four days at high altitude
Blood pressure
Time frame: At sea level (one day, one night) and all four days at high altitude
Sleep oxygen saturation
Time frame: At sea level (one night) and all three nights of the study at high altitude
Sleep apnea hypopnea index
Time frame: At sea level (one night) and all three nights of the study at high altitude
Sleep oxygen desaturation index
Time frame: At sea level (one night) and all three nights of the study at high altitude
Sleep duration
Time frame: At sea level (one night) and all three nights of the study at high altitude
Cancellation Pictures cognitive test
Time frame: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Contrast Sensitivity cognitive test
Time frame: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Digits-in-Noise cognitive test
Time frame: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Spatial Release from Masking cognitive test
Time frame: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Trail Making cognitive test
Time frame: Two consecutive days at sea level, each of the four days at high altitude, and another time at sea level 1-2 weeks after returning from high altitude.
Oxygen saturation in submaximal exercise
Time frame: At sea level (one day) and one day at high altitude
Lactate following submaximal exercise
Time frame: At sea level (one day) and one day at high altitude
Acute Mountain Sickness Score
Time frame: At sea level (one day) and all four days of the study at high altitude
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No. Although general information of mean and standard error data will be indicated in the graphs used for this project, individual data will be shown in as dots in the exposed graphs, and in tables when this is not possible.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLAB51 in people with Probiotics, run by University of California, San Diego at 2 sites in United States.
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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Oxygen saturation (time frame: At sea level (one day, one night) and all four days and three nights of the study at high altitude). 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 14 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.