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The Effect of Dehydration on Intestinal Permeability

Primary Purpose

Dehydration, Indomethacin

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Dehydration by sauna exposure

Indomethacin

About this trial

This is an interventional other trial for Dehydration

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Örebro University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Dehydration by sauna exposure

Indomethacin - Positive control

Negative control

Arm Description

Participants dehydrate using sauna exposure until they lose 3% of their body weight.

Indomethacin is administered to induce increased intestinal permeability

No intervention is performed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Change in gastroduodenal permeability measured as urinary sucrose excretion

Change in quantity of intestinal permeability markers in blood

e.g. fatty acid binding proteins

Change in salivary cortisol levels

Full Information

NCT ID

NCT03620825

First Posted

July 30, 2018

Last Updated

August 2, 2018

Sponsor

Örebro University, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT03620825

Brief Title

The Effect of Dehydration on Intestinal Permeability

Official Title

The Effect of Dehydration on Intestinal Permeability

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

March 17, 2018 (Actual)

Primary Completion Date

June 21, 2018 (Actual)

Study Completion Date

June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Örebro University, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dehydration, Indomethacin

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dehydration by sauna exposure

Arm Type

Experimental

Arm Description

Participants dehydrate using sauna exposure until they lose 3% of their body weight.

Arm Title

Indomethacin - Positive control

Arm Type

Active Comparator

Arm Description

Indomethacin is administered to induce increased intestinal permeability

Arm Title

Negative control

Arm Type

No Intervention

Arm Description

No intervention is performed

Intervention Type

Other

Intervention Name(s)

Dehydration by sauna exposure

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Indomethacin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1-2 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

1-2 weeks

Title

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

Time Frame

1-2 weeks

Title

Change in gastroduodenal permeability measured as urinary sucrose excretion

Time Frame

1-2 weeks

Title

Change in quantity of intestinal permeability markers in blood

Description

e.g. fatty acid binding proteins

Time Frame

1-2 weeks

Title

Change in salivary cortisol levels

Time Frame

1-2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert J Brummer, MD, PhD

Organizational Affiliation

Örebro University, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Örebro University

City

Örebro

State/Province

Örebro County

ZIP/Postal Code

70182

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No individual participant data will be shared

Citations:

PubMed Identifier

34330970

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.

Results Reference

derived

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The Effect of Dehydration on Intestinal Permeability

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