Clinical trial NCT03620825: The Effect of Dehydration on Intestinal Permeability
Official title: The Effect of Dehydration on Intestinal Permeability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Indomethacin
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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) 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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent prior to any study related procedures
2. Age \> 18 till \<50
3. Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study

Exclusion Criteria:

1. Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
2. Current diagnosis of hypertension.
3. Current diagnosis of psychiatric disease.
4. Over 100kg or with a BMI over 35.
5. Systemic use of steroids in the last 6 weeks.
6. Use of antibiotics or antimicrobial medication in the last month.
7. Daily usage of nonsteroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening.
8. Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening.
9. Diagnosed inflammatory gastrointestinal disease.
10. Known organic gastrointestinal disease (e.g. irritable bowel syndrome, inflammatory bowel disease, chronic diarrhoea or constipation).
11. History of or present gastrointestinal malignancy or polyposis.
12. Recent (gastrointestinal) infection (within last 6 months).
13. Eosinophilic disorders of the gastrointestinal tract.
14. Current communicable disease (e.g. upper respiratory tract infection).
15. Malignant disease and /or patients who are receiving systemic anti-neoplastic agents).
16. Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis).
17. Autoimmune disease and/or patients receiving immunosuppressive medications.
18. Major relevant allergies (e.g. food allergy, multiple allergies).
19. Chronic pain syndromes (e.g. fibromyalgia)
20. Chronic fatigue syndrome
21. Regular use of probiotics in the last 6 weeks.
22. Smoking and/or chewable tobacco.
23. Planned changes to current diet or exercise regime.
24. Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening.
25. Use of immunosuppressant drugs within last 4 weeks prior to screening.
26. Women: Pregnancy, lactation.
27. Abuse of alcohol or drugs.
28. Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function.
29. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.

Primary outcomes:
measure: Change in small intestinal permeability measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Change in whole gut permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control
timeFrame: 1-2 weeks
measure: Change in colonic permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control
timeFrame: 1-2 weeks
measure: Change in gastroduodenal permeability measured as urinary sucrose excretion
timeFrame: 1-2 weeks
measure: Change in quantity of intestinal permeability markers in blood
timeFrame: 1-2 weeks
measure: Change in salivary cortisol levels
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
state: Örebro County
Study officials:
affiliation: Örebro University, Sweden
name: Robert J Brummer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.