Status:
COMPLETED
Safety and Efficacy of a Probiotic Supplement
Lead Sponsor:
University of Memphis
Conditions:
Gastrointestinal Discomfort
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have been shown to impro...
Detailed Description
This study is a randomized, placebo-controlled, double-blinded crossover study where trained runners that experience moderate gastrointestinal discomfort with exhaustive runs will be subjected to the ...
Eligibility Criteria
Inclusion
- Males, females between 18-50 years of age
- Healthy and injury free as determined by screening questions and medical history
- Distance runners as determined by physical activity questionnaire; run = 15 miles/week, run = 3 time or more/week
- VO2max level of = 40ml/kg/min for males or = 35ml/kg/min for females
- Agree to maintain normal diet and exercise routine throughout study
- Agrees to collect stool samples as needed
- Agree to complete questionnaires, records
Exclusion
- Women who are pregnant or breastfeeding, or plan to become pregnant during course of the study will not be included as the effect of probiotic on pregnancy and lactation is not established.
- Subjects with a known allergy to the test material (active and placebo)
- Subjects taking NSAIDs, Metformin, probiotics, or supplements that might alter the gut microbiome;these will be assessed individually. (Multivitamin and protein supplementation are allowed)
- Subject that have abnormal test results during screening.
- Alcohol or drug abuse within past year (alcohol can impair gut barrier).
- History of GI surgery within past year as it would alter the gut microbiome (excluding appendectomy and herniorrhaphy).
- Severe heart, liver, kidney, neurological, oncological or psychiatric disease, or immunosuppressed subjects will be excluded.
- Coeliac disease, inflammatory bowel disease or acute pancreatitis (all 3 can impair gut barrier)
- Regular use of antacid medication (can significantly alter microbiota)
- Subject following a low FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) diet will be excluded as this dietary pattern can alter the intestinal response to exercise in some people.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05425329
Start Date
August 1 2020
End Date
December 31 2021
Last Update
June 21 2022
Active Locations (1)
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1
University of Memphis
Memphis, Tennessee, United States, 38152