Safety and Efficacy of a Probiotic Supplement

Completed · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal Discomfort

In brief

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 improve gut permeability through the secretion of mucin, immunoglobulin A and improvement in stability of tight junctions between epithelial cells. This study will determine the efficacy of a probiotic containing the bacterial strains P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485) in altering markers of gut inflammation and dysfunction, and symptoms of gastrointestinal distress.

Key facts

Study ID

NCT05425329

Run by

University of Memphis

People needed

17

Starts

2020-08-01

Expected to finish

2021-12-31

Last updated by the study team

2022-06-21

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Memphis — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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