NCT03027583

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

January 19, 2017

Last Update Submit

May 1, 2018

Conditions

Intestinal Permeability

Outcome Measures

Primary Outcomes (1)

  • Change in small intestine permeability

    The effect of 6 oral supplementation of a probiotic strain versus placebo on small intestinal permeability measured as the change in urinary lactulose:rhamnose ratio following a 1 hour exercise challenge.

    6 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

63 subjects will be randomized to the experimental arm. The experimental product is a vegetable capsule containing a probiotic strain. Subjects will consume 1-2 capsules daily together with breakfast, equivalent to a dose of 50 bill CFU for 6 weeks.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

63 subjects will be randomized to the placebo arm.The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics. Subjects will consume 1-2 capsules daily with breakfast for 6 weeks.

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

6 weeks daily oral intake of a probiotic strain.

Probiotic
PlaceboDIETARY_SUPPLEMENT

6 weeks daily oral intake of placebo.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent prior to any trial related procedures
  • Healthy (gastrointestinal symptoms are allowed, but not needed)
  • Weekly training load ≥ 4 hours within endurance sports as judged by the subject (minimum 1.5 hours of the training must be running activity)
  • Able to complete a 10 km run on a treadmill within 60 minutes, as judged by the subject
  • Willing to abstain from any probiotics products or medication known to alter gastrointestinal function throughout the participation of the trial

You may not qualify if:

  • Abdominal surgery which, as judged by the investigator, might affect the gastrointestinal function (except appendectomy and cholecystectomy)
  • Resting diastolic blood pressure ≥ 90 mmHg
  • Resting systolic blood pressure ≥ 140 mmHg
  • A current diagnosis of psychiatric disease
  • Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
  • Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening
  • Usage of medications, except contraceptives, in the last 2 weeks prior to screening
  • Diagnosed inflammatory gastrointestinal disease
  • Lactose intolerance
  • Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject
  • Participation in other clinical trials in the past 2 months prior to screening
  • Regular use of probiotics in the last 2 months
  • Smoking and/or frequent use of other nicotine products
  • Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial
  • Use of laxatives, anti-diarrheals, anti-cholinergics within last 2 months prior to screening
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantia Food Clinical trials

Cork, Ireland

Location

Related Publications (1)

  • Engel S, Mortensen B, Wellejus A, Vera-Jimenez N, Struve C, Brummer RJ, Damholt A, Woods T, Shanahan F. Safety of Bifidobacterium breve, Bif195, employing a human exercise-induced intestinal permeability model: a randomised, double-blinded, placebo-controlled, parallel group trial. Benef Microbes. 2022 Aug 3;13(3):243-252. doi: 10.3920/BM2021.0173. Epub 2022 Jul 22.

    PMID: 35866597DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fergus Shanahan, Professor

    Cork University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 23, 2017

Study Start

March 1, 2017

Primary Completion

July 30, 2017

Study Completion

September 15, 2017

Last Updated

May 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)