NCT03027583

The Effect of Probiotic Intervention on Intestinal Permeability

The Effect of 6 Weeks Supplementation of Probiotic on Exercise-induced Intestinal Permeability in Trained Subjects - a Randomized, Double-blind, Placebo-controlled, Two Armed Parallel Group Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This trial is a single-site, randomised, double blind, placebo-controlled, two-armed parallel-group trial in healthy adult volunteers. The trial will investigate the effect of oral supplementation of a probiotic strain on the ability to attenuate exercise-induced deterioration of intestinal barrier function and gastrointestinal symptoms.

Detailed description

The trial includes a run-in period of two weeks duration followed by a six weeks intervention period. After having given their written informed consent, subjects will complete screening procedures to evaluate their eligibility for the trial and complete a run-in period of minimum two weeks duration to washout possible pre-trial probiotics. At the screening visit (visit 1), subjects will also perform a VO2max test on a running treadmill to determine their individual VO2max. After baseline assessments at visit 2 and 3, the subjects will be randomly assigned to one of the two treatment groups (active or placebo product) in a ratio of 1:1. The two arms will be stratified for gender. The subjects will consume 1-2 capsules once daily, together with breakfast, for six weeks starting at Day 1, the day after Visit 3. During the entire run-in and intervention period the subjects will be asked not to consume any other probiotic products. During the entire trial subjects should maintain their habitual life style in relation to physical activity level, diet and sleep habits. At Visit 2, 3, 4 and 5, the small intestinal permeability will be evaluated by the L:R ratio measured in urine obtained 5 hours after oral ingestion of a lactulose and rhamnose solution. The permeability test will be performed in combination with a 1 hour treadmill running challenge when performed at Visit 3 and Visit 5. The treadmill run will be performed at a velocity corresponding to 80% of the subjects individually measured VO2max. Faecal, urine and blood samples will be collected at Visit 2, 3, 4 and 5 for evaluation of the secondary objectives. The faecal samples collected will be: First bowel movement post-permeability test at Visit 2, first bowel movement post-exercise test at Visit 3, first bowel movement post-permeability test at Visit 4 and the first bowel movement post-exercise at Visit 5.

Conditions

• Intestinal Permeability

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	6 weeks daily oral intake of a probiotic strain.
DIETARY_SUPPLEMENT	Placebo	6 weeks daily oral intake of placebo.

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-07-30
• Completion: 2017-09-15
• First posted: 2017-01-23
• Last updated: 2018-05-03

Locations

1 site across 1 country: Ireland