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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.
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 probiotic intervention/placebo supplementation for one month with a one month washout period. The intervention consists of the probiotic strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1 at a dose of 3b cfu/day. Probiotic/Placebo capsules will be taken once daily. Biological samples and symptom data collection will be collected at baseline and after one month of probiotic/placebo supplementation. Data are also collected after an in-house treadmill run after one month of supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic treatment | Experimental | P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485 in a ration of 1:1:1 at a dose of 3b cfu/day. |
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| Placebo treatment | Placebo Comparator | Capsules indistinguishable from intervention containing maltodextrin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I3.1 | Dietary Supplement | Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of probiotic supplementation on intestinal fatty acid binding protein (iFABP) levels. | Determine concentration (pg/ml) of iFABP in serum | 4 weeks |
| Effect of probiotic supplementation on lipopolysaccharide binding protein (LBP) levels | Determine concentration (ng/ml) of LBP in serum | 4 weeks |
| Effect of probiotic supplementation on zonulin levels | Determine concentration (ng/ml) of zonulin in serum | 4 weeks |
| Effect of probiotic supplementation on calprotectin levels | Determine concentration (ug/g) of calprotectin in feces. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie van der Merwe, PhD | University of Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Memphis | Memphis | Tennessee | 38152 | United States |
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| Placebo treatment | Dietary Supplement | Capsule containing maltodextrin. |
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