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The effect of probiotic strains on intestinal permeability in well-trained adults

Investigational study on the effect of 6 weeks intake of two probiotic strains on exercise-induced intestinal permeability – a randomized, double-blind, placebo-controlled, three-armed parallel group study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16686476
Enrollment
48
Registered
2015-11-06
Start date
2015-09-21
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal function Digestive System

Interventions

Participants are randomised to one of three treatment arms for six weeks: 1. A capsule containing a probiotic strain A 2. A capsule containing a probiotic strain B 3. A placebo capsule with no probiot

Sponsors

Chr. Hansen A/S (Denmark)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men or women 2. Age 18 to 40 inclusive 3. Presence of upper or lower gastrointestinal symptoms that interfere with training and during competition 4. Weekly training load of 4 or more hours within endurance sports (minimum 50% of the training should be running activity)

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to any of the ingredients of the study products or lactose intolerance 2. History or diagnosis of gastrointestinal disease or complicated gastrointestinal surgery 3. Any physical or psychological abnormality or medical condition that could have an effect on gastrointestinal discomfort 4. Participation in any other clinical study 5. Not willing or able to provide written informed consent for participation in the study 6. For women: Not willing and able to use a reliable contraceptive method, pregnancy, lactation or wish to become pregnant

Design outcomes

Primary

MeasureTime frame
Intestinal permeability after a standardized exercise challenge measured by the in vivo lactulose/rhamnose sugar test at baseline and end of intervention (after 6 weeks)

Secondary

MeasureTime frame
Multiple potential biomarkers measured in blood, feces and saliva at baseline and end of intervention (after 6 weeks)

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026