Safety and Efficacy of a Probiotic Supplement

University of Memphis (Other)
Overall Status
Completed ID

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Actual Enrollment :
17 participants
Intervention Model:
Crossover Assignment
Double (Participant, Investigator)
Primary Purpose:
Official Title:
Safety and Efficacy of a Probiotic Supplement: Focus on Lessening Gastrointestinal Distress in Endurance Athletes
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Effect of probiotic supplementation on intestinal fatty acid binding protein (iFABP) levels. [4 weeks]

    Determine concentration (pg/ml) of iFABP in serum

  2. Effect of probiotic supplementation on lipopolysaccharide binding protein (LBP) levels [4 weeks]

    Determine concentration (ng/ml) of LBP in serum

  3. Effect of probiotic supplementation on zonulin levels [4 weeks]

    Determine concentration (ng/ml) of zonulin in serum

  4. Effect of probiotic supplementation on calprotectin levels [4 weeks]

    Determine concentration (ug/g) of calprotectin in feces.

Eligibility Criteria


Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 University of Memphis Memphis Tennessee United States 38152

Sponsors and Collaborators

  • University of Memphis


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
University of Memphis Identifier:
Other Study ID Numbers:
  • PRO-FY2020-304
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 21, 2022