DehydrationNCT03620825
The Effect of Dehydration on Intestinal Permeability
A study testing Dehydration by sauna exposure and Indomethacin in people with Dehydration and Indomethacin, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
In this study, the effect of dehydration by sauna exposure on the intestinal permeability in 20 healthy subjects is investigated. Participants attend three visits: 1) Sauna visit (to achieve 3% dehydration), 2) Positive control visit (intake of indomethacin which is known to increase intestinal permeability), 3)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Indomethacin
- What is being tested?
- Dehydration by sauna exposure and Indomethacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 17 Mar 2018to 21 Jun 2018
- 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 study related procedures
- Age > 18 till <50
- Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study
Who cannot join
- Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
- Current diagnosis of hypertension.
- Current diagnosis of psychiatric disease.
- Over 100kg or with a BMI over 35.
- Systemic use of steroids in the last 6 weeks.
- Use of antibiotics or antimicrobial medication in the last month.
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- Daily usage of nonsteroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening.
- Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening.
- Diagnosed inflammatory gastrointestinal disease.
- Known organic gastrointestinal disease (e.g. irritable bowel syndrome, inflammatory bowel disease, chronic diarrhoea or constipation).
- History of or present gastrointestinal malignancy or polyposis.
- Recent (gastrointestinal) infection (within last 6 months).
- Eosinophilic disorders of the gastrointestinal tract.
- Current communicable disease (e.g. upper respiratory tract infection).
- Malignant disease and /or patients who are receiving systemic anti-neoplastic agents).
- Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis).
- Autoimmune disease and/or patients receiving immunosuppressive medications.
- Major relevant allergies (e.g. food allergy, multiple allergies).
- Chronic pain syndromes (e.g. fibromyalgia)
- Chronic fatigue syndrome
- Regular use of probiotics in the last 6 weeks.
- Smoking and/or chewable tobacco.
- Planned changes to current diet or exercise regime.
- Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening.
- Use of immunosuppressant drugs within last 4 weeks prior to screening.
- Women: Pregnancy, lactation.
- Abuse of alcohol or drugs.
- Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function.
- Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the effect of dehydration by sauna exposure on the intestinal permeability in 20 healthy subjects is investigated. Participants attend three visits: 1) Sauna visit (to achieve 3% dehydration), 2) Positive control visit (intake of indomethacin which is known to increase intestinal permeability), 3) Negative control visit. At all visits, saliva samples, blood samples, faecal samples, saliva samples are collected and the multi-sugar permeability test is performed. In this test, participants drink a sugar solution and then urine collect urine for 5 and 24 h. The ratio of the sugars detected in the urine by liquid chromatography/mass spectometry is a reflection of the intestinal permeability. Saliva samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples are collected for assessment of markers of intestinal barrier function and inflammation.
- Conditions
- Dehydration, Indomethacin
- Being tested
- Dehydration by sauna exposure, Indomethacin
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydration by sauna exposureOther
Participants repeatedly undergo sauna exposures until they loose 3% of their body weight.
IndomethacinDrug
Participants take indomethacin in tablet form the evening before and the morning of the visit to induce intestinal permeability
| Study group | Role | What they receive |
|---|---|---|
| Dehydration by sauna exposure | Experimental | Participants dehydrate using sauna exposure until they lose 3% of their body weight. Receives: Other: Dehydration by sauna exposure |
| Indomethacin - Positive control | Active comparator | Indomethacin is administered to induce increased intestinal permeability Receives: Drug: Indomethacin |
| Negative control | No intervention | No intervention is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in small intestinal permeability measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
Measured: 1-2 weeks
Secondary outcomes (5)
Change in whole gut permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Measured: 1-2 weeks
Change in colonic permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Measured: 1-2 weeks
Change in gastroduodenal permeability measured as urinary sucrose excretion
Measured: 1-2 weeks
Change in quantity of intestinal permeability markers in blood
e.g. fatty acid binding proteins
Measured: 1-2 weeks
Change in salivary cortisol levels
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start17 Mar 2018
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
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 DehydrationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Brummer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620825
- Sponsor's protocol ID
- 2017/463
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Publications
Roca Rubio MF, Eriksson U, Brummer RJ, Konig J. Sauna dehydration as a new physiological challenge model for intestinal barrier function. Sci Rep. 2021 Jul 30;11(1):15514. doi: 10.1038/s41598-021-94814-0.
PubMed 34330970
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dehydration on Intestinal Permeability
- ClinicalTrials.gov ID
- NCT03620825
- Acronym / sponsor ID
- 2017/463
- Conditions
- Dehydration, Indomethacin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 8 Aug 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.
In this study, the effect of dehydration by sauna exposure on the intestinal permeability in 20 healthy subjects is investigated. Participants attend three visits: 1) Sauna visit (to achieve 3% dehydration), 2) Positive control visit (intake of indomethacin which is known to increase intestinal permeability), 3) Negative control visit. At all visits, saliva samples, blood samples, faecal samples, saliva samples are collected and the multi-sugar permeability test is performed. In this test, participants drink a sugar solution and then urine collect urine for 5 and 24 h. The ratio of the sugars detected in the urine by liquid chromatography/mass spectometry is a reflection of the intestinal permeability. Saliva samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples are collected for assessment of markers of intestinal barrier function and inflammation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dehydration by sauna exposure | Experimental | Other: Dehydration by sauna exposureParticipants dehydrate using sauna exposure until they lose 3% of their body weight. |
| Indomethacin - Positive control | Active comparator | Drug: IndomethacinIndomethacin is administered to induce increased intestinal permeability |
| Negative control | No intervention | –No intervention is performed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent prior to any study related procedures
- Age > 18 till <50
- Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study
Key exclusion criteria (29 listed)
- Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
- Current diagnosis of hypertension.
- Current diagnosis of psychiatric disease.
- Over 100kg or with a BMI over 35.
- Systemic use of steroids in the last 6 weeks.
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 |
|---|---|---|
| Dehydration by sauna exposureParticipants repeatedly undergo sauna exposures until they loose 3% of their body weight. | Other | Dehydration by sauna exposure |
| IndomethacinParticipants take indomethacin in tablet form the evening before and the morning of the visit to induce intestinal permeability | Drug | Indomethacin - Positive control |
Primary outcome
Change in small intestinal permeability measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
Time frame: 1-2 weeks
5 secondary outcomes
Change in whole gut permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Time frame: 1-2 weeks
Change in colonic permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control
Time frame: 1-2 weeks
Change in gastroduodenal permeability measured as urinary sucrose excretion
Time frame: 1-2 weeks
Change in quantity of intestinal permeability markers in blood
Time frame: 1-2 weeks
Change in salivary cortisol levels
Time frame: 1-2 weeks
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 8 Aug 2018.
- Derived from this study: PubMed 34330970Roca Rubio MF, Eriksson U, Brummer RJ, Konig J. Sauna dehydration as a new physiological challenge model for intestinal barrier function. Sci Rep. 2021 Jul 30;11(1):15514. doi: 10.1038/s41598-021-94814-0.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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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.
Robert J Brummer, MD, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydration by sauna exposure and Indomethacin in people with Dehydration and Indomethacin, run by Örebro University, Sweden at 1 site in Sweden.
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 3 inclusion and 29 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 8 Aug 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 Sweden. 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. 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 intestinal permeability measured as the urinary lactulose/rhamnose secretion ratio compared to negative control (time frame: 1-2 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 NCT03620825, 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 8 Aug 2018.