Probiotic for High Altitude Acclimatization

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

17 Participants Needed

Trial Summary

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 evidence supports the effectiveness of the treatment SLAB51 for high altitude acclimatization?

Research shows that probiotics, like those in SLAB51, can help improve gut health and reduce inflammation in high-altitude conditions. Studies on similar treatments have demonstrated benefits in maintaining gut microbiota balance and reducing altitude-related health issues. ^{1 2 3 4 5}

Is the probiotic SLAB51 safe for human use?

A Phase I safety study of a similar probiotic, Lactobacillus reuteri, in healthy adults showed no evidence of harmful effects or infections, suggesting it is generally safe for human use. ^{1 2 3 5 6}

How does the treatment SLAB51 differ from other treatments for high altitude acclimatization?

SLAB51 is unique because it is a probiotic treatment that targets the gut microbiome to help with high altitude acclimatization, unlike other treatments that may not focus on gut health. It uses beneficial bacteria to potentially improve gut function and reduce inflammation, which can be disrupted at high altitudes. ^{1 3 4 5 7}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

I have a history of heart or lung disease.

No exclusion criteria based on languages spoken.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Dynamics of predominant microbiota in the human gastrointestinal tract and change in luminal enzymes and immunoglobulin profile during high-altitude adaptation. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of Lactobacillus casei Shirota ingestion on common cold infection and herpes virus antibodies in endurance athletes: a placebo-controlled, randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Synbiotics on Amelioration of Intestinal Inflammation Under Hypobaric Hypoxia. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Oxygen enrichment protects against intestinal damage and gut microbiota disturbance in rats exposed to acute high-altitude hypoxia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Gut Microbiome-Targeted Modulations Regulate Metabolic Profiles and Alleviate Altitude-Related Cardiac Hypertrophy in Rats. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A phase one safety study of Lactobacillus reuteri conducted in the Peruvian Amazon: Observations from the field. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Probiotics isolated from yaks improves the growth performance, antioxidant activity, and cytokines related to immunity and inflammation in mice. [2020]