MedTrace Logo

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

NCT06552806 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-08-14

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

SLAB51

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552806 on ClinicalTrials.gov