Permeability; IncreasedProSPerNCT03408691
PRObiotic and Stress-related PERmeability
A study testing Fresh fermented dairy drink containing probiotic strain and Acidified dairy drink without ferment in people with Permeability; Increased, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in students defending a bachelor's or master's thesis in front of a jury at the University of Leuven (Belgium). Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Permeability; Increased
- What is being tested?
- Fresh fermented dairy drink containing probiotic strain and Acidified dairy drink without ferment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jan 2018to 31 Mar 2019
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student defending a bachelor's or master's thesis in front of a jury
- Age 20 till 30 years (both included), both genders
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study
- Subject willing to consume 2 units of investigational product per day during the investigational product consumption period.
- For females: If of child bearing potential, female subjects must be using or complying with methods of contraception
- Subject willing to strictly follow dietary/medication instructions for the entire duration of the study
- Subject must have access to a refrigerator with adequate space to store the investigational products according to the labels' storage recommendations and a freezer for the cooling elements in the transport bag
Who cannot join
- Subject with chronic gastrointestinal disorders or symptoms, type 1 or type 2 diabetes mellitus, psychiatric disease including but not limited to depression (screened by PHQ-9) and general anxiety disorder (screened by GAD-7), celiac disease, food allergy or a history of atopic conditions (eczema, allergic asthma, allergic rhinoconjunctivitis) requiring active treatment
- Subject with allergy or intolerance to non-steroidal anti-inflammatory drugs (NSAID)
- Subject with first degree relatives with coeliac disease, inflammatory bowel disease (IBD) or type 1 diabetes
- Subject with known or suspected lactose intolerance or suspected allergy or hypersensitivity to any component of the study product(s) (e.g. milk protein)
- Subject receiving (currently or in the 2 last weeks) systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, NSAIDs and steroids prescribed in chronic inflammatory diseases.
- Active smoker with at least 7 cigarettes per week
- Subject consuming regularly (>1/week) more than 3 units of alcohol per day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Probiotic Strain on Stress-related Intestinal Hyperpermeability in Adult Humans.
This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in students defending a bachelor's or master's thesis in front of a jury at the University of Leuven (Belgium).
Read the detailed description
The study is conceived as a single-site exploratory study with a randomized, controlled, parallel group design. There will be a double blind with 2 intervention arms (Test product with probiotic and acidified milk Control) plus an extra open label arm without intervention in a 2:2:1 ratio. The goal of the open-label arm is to confirm our previous data on the effect of stress on small intestinal permeability (see reference), without powering the study to detect a significant difference within this open-label arm. The participants and the investigators are blinded to the allocation to the probiotic vs. acidified milk control arm. However, there is no blinding in the arm without intervention.
In vivo intestinal permeability and salivary markers of psychological stress and activation of the autonomous nervous system will be measured and questionnaires will be completed at 4 different test days: baseline (V2), two weeks after randomization (V3), during an oral defense of a master's or bachelor's thesis (V4) and finally after pretreatment with Indomethacin (V5).
The 5 study visits are organized around the thesis defence (D0):
V1 (screening + inclusion) takes place within 2 to 3 weeks prior to the randomization.
V2 (baseline + randomization) will take place between D-35 to D-27. V3 (randomization + 2 weeks) will take place at D-14 +/-1day. V4 (thesis defense) is D0 and organized by the University. V5 (Indomethacin) will take place at D+14 +/-1day.
For subjects in the intervention arm (Test product with probiotic and acidified milk Control), products will be supplied (for 1 week). In addition, alternate product supply will take place at D-21, D-7 and D+7 (each one +/-1day).
- Conditions
- Permeability; Increased
- Being tested
- Fresh fermented dairy drink containing probiotic strain, Acidified dairy drink without ferment
- Keywords
- probiotic, permeability, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh fermented dairy drink containing probiotic strainDietary supplement
Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks.
Acidified dairy drink without fermentOther
Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test product | Active comparator | Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks Receives: Dietary Supplement: Fresh fermented dairy drink containing probiotic strain |
| Control product | Placebo comparator | Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks Receives: Other: Acidified dairy drink without ferment |
| No product | No intervention | no product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactulose-Mannitol Ratio (LMR) during the stress condition vs. baseline
LMR or in vivo small intestinal permeability during stress condition vs. baseline in the Test product with probiotic compared to the acidified milk Control arm
Measured: oral administration of Test or Control product for 4 weeks before stress condition
Secondary outcomes (4)
LMR during administration of Test or Control product vs. baseline
LMR or in vivo small intestinal permeability during administration vs. baseline within each intervention arm and between groups.
Measured: oral administration of Test or Control product for 2 weeks
LMR after indomethacin vs. baseline
LMR or in vivo small intestinal permeability after indomethacin vs. baseline within each intervention arm and between groups
Measured: oral administration of Test or Control product for 6 weeks before indomethacin
Salivary cortisol during the stress condition vs. baseline
Salivary cortisol during the stress condition vs. baseline within each intervention arm and between groups
Measured: oral administration of Test or Control product for 4 weeks before stress condition
Subjective anxiety levels (STAI state) during the stress condition vs. baseline
Subjective anxiety levels (STAI state) during the stress condition vs. baseline within each intervention arm and between groups
Measured: oral administration of Test or Control product for 4 weeks before stress condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start23 Jan 2018
- Primary completion22 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Permeability; IncreasedStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-site exploratory randomized, controlled interventional trial with a parallel group design: double blind with Test and Control arm + open label arm without intervention.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Vanuytsel, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408691
- Sponsor's protocol ID
- S60969
- Acronym
- ProSPer
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanuytsel T, van Wanrooy S, Vanheel H, Vanormelingen C, Verschueren S, Houben E, Salim Rasoel S, Tomicronth J, Holvoet L, Farre R, Van Oudenhove L, Boeckxstaens G, Verbeke K, Tack J. Psychological stress and corticotropin-releasing hormone increase intestinal permeability in humans by a mast cell-dependent mechanism. Gut. 2014 Aug;63(8):1293-9. doi: 10.1136/gutjnl-2013-305690. Epub 2013 Oct 23.
PubMed 24153250Wauters L, Van Oudenhove L, Accarie A, Geboers K, Geysen H, Toth J, Luypaerts A, Verbeke K, Smokvina T, Raes J, Tack J, Vanuytsel T. Lactobacillus rhamnosus CNCM I-3690 decreases subjective academic stress in healthy adults: a randomized placebo-controlled trial. Gut Microbes. 2022 Jan-Dec;14(1):2031695. doi: 10.1080/19490976.2022.2031695.
PubMed 35130109
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Probiotic Strain on Stress-related Intestinal Hyperpermeability in Adult Humans.
- ClinicalTrials.gov ID
- NCT03408691
- Acronym / sponsor ID
- ProSPer / S60969
- Conditions
- Permeability; Increased
- Keywords
- probiotic, permeability, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- 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 is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in students defending a bachelor's or master's thesis in front of a jury at the University of Leuven (Belgium).
Detailed description
The study is conceived as a single-site exploratory study with a randomized, controlled, parallel group design. There will be a double blind with 2 intervention arms (Test product with probiotic and acidified milk Control) plus an extra open label arm without intervention in a 2:2:1 ratio. The goal of the open-label arm is to confirm our previous data on the effect of stress on small intestinal permeability (see reference), without powering the study to detect a significant difference within this open-label arm. The participants and the investigators are blinded to the allocation to the probiotic vs. acidified milk control arm. However, there is no blinding in the arm without intervention.
In vivo intestinal permeability and salivary markers of psychological stress and activation of the autonomous nervous system will be measured and questionnaires will be completed at 4 different test days: baseline (V2), two weeks after randomization (V3), during an oral defense of a master's or bachelor's thesis (V4) and finally after pretreatment with Indomethacin (V5).
The 5 study visits are organized around the thesis defence (D0):
V1 (screening + inclusion) takes place within 2 to 3 weeks prior to the randomization.
V2 (baseline + randomization) will take place between D-35 to D-27. V3 (randomization + 2 weeks) will take place at D-14 +/-1day. V4 (thesis defense) is D0 and organized by the University. V5 (Indomethacin) will take place at D+14 +/-1day.
For subjects in the intervention arm (Test product with probiotic and acidified milk Control), products will be supplied (for 1 week). In addition, alternate product supply will take place at D-21, D-7 and D+7 (each one +/-1day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Single-site exploratory randomized, controlled interventional trial with a parallel group design: double blind with Test and Control arm + open label arm without intervention.
| Arm | Type | Receives |
|---|---|---|
| Test product | Active comparator | Dietary Supplement: Fresh fermented dairy drink containing probiotic strainFresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks |
| Control product | Placebo comparator | Other: Acidified dairy drink without fermentAcidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks |
| No product | No intervention | –no product |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Student defending a bachelor's or master's thesis in front of a jury
- Age 20 till 30 years (both included), both genders
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study
- Subject willing to consume 2 units of investigational product per day during the investigational product consumption period.
- For females: If of child bearing potential, female subjects must be using or complying with methods of contraception
Key exclusion criteria (7 listed)
- Subject with chronic gastrointestinal disorders or symptoms, type 1 or type 2 diabetes mellitus, psychiatric disease including but not limited to depression (screened by PHQ-9) and general anxiety disorder (screened by GAD-7), celiac disease, food allergy or a history of atopic conditions (eczema, allergic asthma, allergic rhinoconjunctivitis) requiring active treatment
- Subject with allergy or intolerance to non-steroidal anti-inflammatory drugs (NSAID)
- Subject with first degree relatives with coeliac disease, inflammatory bowel disease (IBD) or type 1 diabetes
- Subject with known or suspected lactose intolerance or suspected allergy or hypersensitivity to any component of the study product(s) (e.g. milk protein)
- Subject receiving (currently or in the 2 last weeks) systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, NSAIDs and steroids prescribed in chronic inflammatory diseases.
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 |
|---|---|---|
| Fresh fermented dairy drink containing probiotic strainFresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks. | Dietary supplement | Test product |
| Acidified dairy drink without fermentAcidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks. | Other | Control product |
Primary outcome
Lactulose-Mannitol Ratio (LMR) during the stress condition vs. baseline
Time frame: oral administration of Test or Control product for 4 weeks before stress condition
LMR or in vivo small intestinal permeability during stress condition vs. baseline in the Test product with probiotic compared to the acidified milk Control arm
4 secondary outcomes
LMR during administration of Test or Control product vs. baseline
Time frame: oral administration of Test or Control product for 2 weeks
LMR after indomethacin vs. baseline
Time frame: oral administration of Test or Control product for 6 weeks before indomethacin
Salivary cortisol during the stress condition vs. baseline
Time frame: oral administration of Test or Control product for 4 weeks before stress condition
Subjective anxiety levels (STAI state) during the stress condition vs. baseline
Time frame: oral administration of Test or Control product for 4 weeks before stress condition
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 4 Jun 2019.
- Background: PubMed 24153250Vanuytsel T, van Wanrooy S, Vanheel H, Vanormelingen C, Verschueren S, Houben E, Salim Rasoel S, Tomicronth J, Holvoet L, Farre R, Van Oudenhove L, Boeckxstaens G, Verbeke K, Tack J. Psychological stress and corticotropin-releasing hormone increase intestinal permeability in humans by a mast cell-dependent mechanism. Gut. 2014 Aug;63(8):1293-9. doi: 10.1136/gutjnl-2013-305690. Epub 2013 Oct 23.
- Derived from this study: PubMed 35130109Wauters L, Van Oudenhove L, Accarie A, Geboers K, Geysen H, Toth J, Luypaerts A, Verbeke K, Smokvina T, Raes J, Tack J, Vanuytsel T. Lactobacillus rhamnosus CNCM I-3690 decreases subjective academic stress in healthy adults: a randomized placebo-controlled trial. Gut Microbes. 2022 Jan-Dec;14(1):2031695. doi: 10.1080/19490976.2022.2031695.
- 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.
Tim Vanuytsel, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh fermented dairy drink containing probiotic strain and Acidified dairy drink without ferment in people with Permeability; Increased, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 inclusion and 7 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 4 Jun 2019. 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 Belgium. 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?
Lactulose-Mannitol Ratio (LMR) during the stress condition vs. baseline (time frame: oral administration of Test or Control product for 4 weeks before stress condition). 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 NCT03408691, which also lists 2 linked publications.
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 4 Jun 2019.