Probiotic for High Altitude Acclimatization

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Ibuprofen, Anti-hypertensives, Benzodiazepines, others

Disqualifiers: Cardiovascular, Pulmonary, Renal, Neurological, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the probiotic SLAB51 can help people acclimate better to high altitudes by improving blood oxygen levels. Participants will take either the probiotic or a placebo (a non-active substance) during two separate stays at a high-altitude research center. Researchers will monitor various health metrics, including oxygen saturation, heart rate, and sleep quality. People who are generally healthy, haven't traveled above 2,500 meters recently, don't smoke, and have no chronic diseases might be a good fit for this study.

As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially benefit from improved acclimation to high altitudes.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications that could affect the study's measurements, like ibuprofen, blood pressure medications, and sleep aids. If you're on any of these, you might not be able to participate.

What prior data suggests that the probiotic SLAB51 is safe for high-altitude acclimatization?

Research shows that SLAB51, a probiotic with multiple strains, is generally safe for people. In past studies, SLAB51 improved oxygen levels and reduced symptoms of Acute Mountain Sickness (AMS) at high altitudes. While these results are encouraging, no major reports of side effects or harmful reactions have emerged. This indicates that people taking SLAB51 usually did not experience discomfort or negative effects. As a probiotic, SLAB51 is similar to the beneficial bacteria found in some foods and supplements, which are often safe for many people. However, considering personal health and consulting a healthcare provider before joining any trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SLAB51 for high altitude acclimatization because it uses a unique approach involving probiotics. Unlike standard treatments that might focus on medications like acetazolamide, which helps by changing the blood's acidity to improve breathing, SLAB51 introduces a massive dose of beneficial bacteria, around 800 billion per serving, to potentially support the body's natural adjustment to high altitudes. This method is groundbreaking as it seeks to leverage gut health to enhance acclimatization, potentially offering a more natural and holistic alternative to traditional drugs.

What evidence suggests that SLAB51 might be an effective treatment for high-altitude acclimatization?

Research shows that the probiotic SLAB51, which participants in this trial may receive, may help people adjust to high altitudes. Studies have found that it increases oxygen levels in the body both during the day and at night, which is important in areas with thinner air. SLAB51 also reduces symptoms of Acute Mountain Sickness (AMS), easing altitude adjustment. It appears to improve breathing, allowing the body to take in more oxygen. These findings suggest that SLAB51 might make high-altitude trips more comfortable and safer. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people who are healthy but want to see if a probiotic called SLAB51 helps with getting used to high altitudes. Participants will take the probiotic or a placebo before and during stays at a high-altitude research station.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study.

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, effective contraception must be used at least 1 month prior to the beginning of the first trip, and in between the first and the second trip.

Exclusion Criteria

My BMI is over 35.

No exclusion criteria based on languages spoken.

Participants with a STOP-Bang Score equal to or higher than 3 will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Participants complete baseline measurements at sea level, including physiological and cognitive assessments

2 days

2 visits (in-person)

First Acclimatization Period

Participants take SLAB51 or placebo three times daily during a three-night acclimatization period at high altitude, with physiological and cognitive assessments

4 days

1 visit (in-person at high altitude)

Washout Period

A washout period of at least six weeks between acclimatization periods

6 weeks

Second Acclimatization Period

Participants take the alternate treatment (SLAB51 or placebo) during a second three-night acclimatization period at high altitude, with repeat assessments

4 days

1 visit (in-person at high altitude)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at sea level

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SLAB51

Trial Overview The study tests whether SLAB51 improves oxygen levels in the blood at high altitude compared to a placebo. It involves taking the substance three times daily over two separate three-night periods at an elevation of 3,801 meters, with various health measurements taken.

How Is the Trial Designed?

Group I: Probiotic group Experimental Treatment 1 Intervention

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.

Group II: Placebo group Placebo Group 1 Intervention

Placebo will be administered in the other trip, following the same schedule as SLAB51 as described above.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S258900422500313X

Improved oxygen saturation and acclimatization with ... Our findings show that probiotic ingestion increases daytime and nighttime O2 saturation, decreases symptoms of AMS, and increases ventilation ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06552806

Multi-strain Probiotic 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.

3. wmrc.edu wmrc.edu/project/testing-the-effect-of-a-probiotic-slab51-on-acclimatization-to-high-altitude-at-barcroft-station/

Testing the effect of a probiotic SLAB51 on acclimatization ... We are seeing evidence that ingestion of this probiotic may improve oxygen saturation, ultimately aiding acclimatization to high altitude.

4. researchgate.net researchgate.net/publication/389060286_Improved_oxygen_saturation_and_acclimatization_with_bacteriotherapy_at_high_altitude

Improved oxygen saturation and acclimatization with ... High altitude imposes physiological stress on the human body due to reduced oxygen availability, and options to improve acclimatization are limited.

5. researchgate.net researchgate.net/publication/380776151_SLAB51_Probiotic_Improves_Oxygen_Saturation_and_Acute_Mountain_Sickness_Score_at_High_Altitude?_share=1

SLAB51 Probiotic Improves Oxygen Saturation and Acute ... Our results indicate that SLAB51 ingestion at high altitudeimproved SpO 2 compared to a placebo and may improve acclimatization to high altitude. Funding: LEA ...

6. app.trialscreen.org app.trialscreen.org/trials/effect-multi-strain-probiotic-on-acclimatization-to-high-altitude-trial-nct06552806

The Effect of a Multi-strain Probiotic on Acclimatization to ... The goal of this study is to learn if the probiotic SLAB51 (Sivomixx800®) works to enhance acclimatization to high altitude in humans.

7. journals.physiology.org journals.physiology.org/doi/abs/10.1152/ajpregu.00321.2021

Differential effects of high-altitude exposure on markers ... SLAB51 Probiotic Improves Oxygen Saturation and Acute Mountain Sickness Score at High Altitude. May 2024 Physiology. Information & Authors. Information Authors ...

8. researchgate.net researchgate.net/publication/376692573_The_probiotic_SLAB51_as_agent_to_counteract_BPA_toxicity_on_zebrafish_gut_microbiota_-liver-brain_axis

The probiotic SLAB51 as agent to counteract BPA toxicity ... In a study on the toxicity of probiotic mixture SLB51 against the toxicity of BPA to zebrafish, it was found that the combined administration of ...