The Effect of Dehydration on Intestinal Permeability

Dehydration Clinical Trial

Official title:

The Effect of Dehydration on Intestinal Permeability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620825
• Other study ID #: 2017/463
• Status: Completed
• Phase: N/A
• Start date: March 17, 2018
• Est. completion date: June 21, 2018

Study information

• Verified date: August 2018
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Indomethacin

Intervention

Other:
• Dehydration by sauna exposure
Participants repeatedly undergo sauna exposures until they loose 3% of their body weight.

Drug:
• Indomethacin
Participants take indomethacin in tablet form the evening before and the morning of the visit to induce intestinal permeability

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro	Örebro County

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in small intestinal permeability measured as the urinary lactulose/rhamnose secretion ratio compared to negative control		1-2 weeks
Secondary	Change in whole gut permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control		1-2 weeks
Secondary	Change in colonic permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control		1-2 weeks
Secondary	Change in gastroduodenal permeability measured as urinary sucrose excretion		1-2 weeks
Secondary	Change in quantity of intestinal permeability markers in blood	e.g. fatty acid binding proteins	1-2 weeks
Secondary	Change in salivary cortisol levels		1-2 weeks