MedTrace Logo

Safety and Efficacy of a Probiotic Supplement

NCT05425329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-06-21

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Discomfort

Interventions

DIETARY_SUPPLEMENT

I3.1

Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1.

DIETARY_SUPPLEMENT

Placebo treatment

Capsule containing maltodextrin.

Sponsors & Collaborators

  • University of Memphis

    lead OTHER

Principal Investigators

  • Marie van der Merwe, PhD · University of Memphis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425329 on ClinicalTrials.gov