Safety and Efficacy of a Probiotic Supplement

Safety and Efficacy of a Probiotic Supplement: Focus on Lessening Gastrointestinal Distress in Endurance Athletes

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Discomfort
• Intervention / Treatment: Dietary supplement: I3.1; Dietary supplement: Placebo treatment

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 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • University of Memphis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic treatment; 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.	Dietary supplement: I3.1; Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1.
Placebo Comparator: Placebo treatment; Capsules indistinguishable from intervention containing maltodextrin.	Dietary supplement: Placebo treatment; Capsule containing maltodextrin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Memphis
• Investigators: Principal Investigator: Marie van der Merwe, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PRO-FY2020-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No