Safety and Efficacy of a Probiotic Supplement

Sponsor

University of Memphis (Other)

Overall Status

Completed

CT.gov ID

NCT05425329

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

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
Gastrointestinal Discomfort	Dietary Supplement: I3.1 Dietary Supplement: Placebo treatment	N/A

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:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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.

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

Effect of probiotic supplementation on intestinal fatty acid binding protein (iFABP) levels. [4 weeks]
Determine concentration (pg/ml) of iFABP in serum
Effect of probiotic supplementation on lipopolysaccharide binding protein (LBP) levels [4 weeks]
Determine concentration (ng/ml) of LBP in serum
Effect of probiotic supplementation on zonulin levels [4 weeks]
Determine concentration (ng/ml) of zonulin in serum
Effect of probiotic supplementation on calprotectin levels [4 weeks]
Determine concentration (ug/g) of calprotectin in feces.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

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

Sponsors and Collaborators

University of Memphis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Memphis

ClinicalTrials.gov Identifier:

NCT05425329

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