Safety and Efficacy of a Probiotic Supplement

NCT05425329 | Completed

• 1 other identifier: PRO-FY2020-304
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Discomfort

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Dietary Supplement: I3.1

Placebo treatment

PLACEBO COMPARATOR

Capsules indistinguishable from intervention containing maltodextrin.

Dietary Supplement: Placebo treatment

Interventions

I3.1 DIETARY_SUPPLEMENT

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

Probiotic treatment

Placebo treatment DIETARY_SUPPLEMENT

Capsule containing maltodextrin.

Placebo treatment

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

University of Memphis

Memphis, Tennessee, 38152, United States

Location

Study Officials

• Marie van der Merwe, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 21, 2022
• Study Start: August 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)