The Effect of a Multi-strain Probiotic on Acclimatization to High Altitude

NCT06552806 | Active Not Recruiting

• 1 other identifier: 807971
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Probiotics

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At sea level (one day) and one day at high altitude

• Heart rate

  At sea level (one day, one night) and all four days at high altitude

• Heart rate variability

  At sea level (one day, one night) and all four days at high altitude

• Blood pressure

  At sea level (one day, one night) and all four days at high altitude

• Sleep oxygen saturation

  At sea level (one night) and all three nights of the study at high altitude

Study Arms (2)

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.

Dietary Supplement: SLAB51

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: SLAB51

Interventions

SLAB51 DIETARY_SUPPLEMENT

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.

Also known as: Oxxyslab

Placebo group; Probiotic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

White Mountain Research Station

Bishop, California, 93514, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Our collaborators Massimiliano Marazzato, PhD (Sapienza University of Rome) and Claudio de Simone, MD, PhD (https://www.probiotixx.info/en/about/) will provide both placebo and treatment samples codified, and their true formulation will be revealed to the investigators at UCSD after all the experiments and analysis are performed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Repeated measurement double-blind, placebo controlled, cross-over study

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 14, 2024
• Study Start: June 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)