The Effect of Dehydration on Intestinal Permeability

NCT03620825 | Completed

• 1 other identifier: 2017/463
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration; Indomethacin

Outcome Measures

Primary Outcomes (1)

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

  1-2 weeks

Secondary Outcomes (5)

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

  1-2 weeks

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

  1-2 weeks

• Change in gastroduodenal permeability measured as urinary sucrose excretion

  1-2 weeks

• Change in quantity of intestinal permeability markers in blood

  1-2 weeks

• Change in salivary cortisol levels

  1-2 weeks

Study Arms (3)

Dehydration by sauna exposure

EXPERIMENTAL

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

Other: Dehydration by sauna exposure

Indomethacin - Positive control

ACTIVE COMPARATOR

Indomethacin is administered to induce increased intestinal permeability

Drug: Indomethacin

Negative control

NO INTERVENTION

No intervention is performed

Interventions

Dehydration by sauna exposure OTHER

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

Dehydration by sauna exposure

Indomethacin DRUG

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

Indomethacin - Positive control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, Örebro County, 70182, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34330970 DERIVED

MeSH Terms

Conditions

Dehydration

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert J Brummer, MD, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 8, 2018
• Study Start: March 17, 2018
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)