Status:
ACTIVE_NOT_RECRUITING
The Effect of a Multi-strain Probiotic on Acclimatization to High Altitude
Lead Sponsor:
University of California, San Diego
Conditions:
Probiotics
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ox...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06552806
Start Date
June 1 2023
End Date
October 1 2026
Last Update
August 14 2024
Active Locations (2)
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1
White Mountain Research Station
Bishop, California, United States, 93514
2
University of California, San Diego
La Jolla, California, United States, 92093