Intestinal PermeabilityNCT03027583
The Effect of Probiotic Intervention on Intestinal Permeability
A study testing Probiotic in people with Intestinal Permeability, run by Chr Hansen at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Permeability
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteIreland
- Study dates
- 1 Mar 2017to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Use of immunosuppressant drugs within last 4 weeks prior to screening
- Women: Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
6 weeks daily oral intake of a probiotic strain.
PlaceboDietary supplement
6 weeks daily oral intake of placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion30 Jul 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal PermeabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Signifikans ApS
- Responsible party
- Sponsor
- Investigators
- Fergus Shanahan, Professor, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027583
- Sponsor's protocol ID
- HND-GI-023
- Status last verified
- Apr 2018
- First submitted
- 19 Jan 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35866597
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03027583
- Acronym / sponsor ID
- HND-GI-023
- Conditions
- Intestinal Permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Signifikans ApS
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic63 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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo63 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic6 weeks daily oral intake of a probiotic strain. | Dietary supplement | Probiotic |
| Placebo6 weeks daily oral intake of placebo. | Dietary supplement | Placebo |
Primary outcome
Change in small intestine permeability
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 35866597Engel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fergus Shanahan, Professor principal investigator
Cork University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Intestinal Permeability, run by Chr Hansen at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in small intestine permeability (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.