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Completed

NCT Number: NCT03620825

The Effect of Dehydration on Intestinal Permeability

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, Örebro County, 70182, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Dehydration by sauna exposure

Other

Participants repeatedly undergo sauna exposures until they loose 3% of their body weight.

Indomethacin

Drug

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

Primary outcomes

  1. Change in small intestinal permeability measured as the urinary lactulose/rhamnose secretion ratio compared to negative control

    Time frame: 1-2 weeks

Secondary outcomes

  1. Change in whole gut permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control

    Time frame: 1-2 weeks

  2. Change in colonic permeability measured as the urinary sucralose/erythritol secretion ratio compared to negative control

    Time frame: 1-2 weeks

  3. Change in gastroduodenal permeability measured as urinary sucrose excretion

    Time frame: 1-2 weeks

  4. Change in quantity of intestinal permeability markers in blood

    Time frame: 1-2 weeks

    e.g. fatty acid binding proteins

  5. Change in salivary cortisol levels

    Time frame: 1-2 weeks

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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