UVB: Skin to Gut Study
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|ClinicalTrials.gov Identifier: NCT03962673|
Recruitment Status : Completed
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Radiation: NB-UVB light exposure||Not Applicable|
To explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinal microbiota composition in humans and confirm a regulatory skin-to-gut axis during baseline conditions.
Humans exposed to UVB-NB light will show changes in the intestinal microbiota composition with the selection of certain phyla of bacteria.
To date, there is no data that describes a biological response to UVB light in the body that affects the intestinal microbiota. Changes in the intestinal microbiota composition caused by NB-UVB phototherapy could be beneficial for patients with chronic/auto-inflammatory diseases like IBD by removing dangerous bacteria, increasing beneficial bacteria, and ultimately modulating immune responses.
- Establish if there is a skin regulatory response towards NB-UVB light in humans.
- Examine what changes in the microbiota composition can be observed on bacterial phyla and class level.
- Determine if this research is worth pursuing in a larger cohort.
During the first visit, the skin type will be assessed by using the Fitzpatrick skin type questionnaire.
Subsequently, subjects will be exposed three times within one week to full body NB-UVB light in The Skin Care Centre to a sub erythemic dose (cause slight redness of the skin but not burning). The exposures will happen during the winter months to prevent UVB exposure from the sun during daily activities to interfere with our observations. Stool samples will be collected before the first exposure (2x) and after the last exposure (2x) to analyze the microbiota composition. Also, serum vitamin D (25-hydroxy vitamin D) will be measured before and after the UVB exposure as a marker of previous UVB exposure before the experiment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants are receiving the same treatment of which the UVB dose is adjusted for the participants Fitzpatrick skin type.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Intestinal Microbiota Changes After Ultra Violet Radiation B Exposure|
|Actual Study Start Date :||February 19, 2018|
|Actual Primary Completion Date :||April 27, 2018|
|Actual Study Completion Date :||February 26, 2019|
Experimental: UVB- exposure
Each participant will receive a pre-determined dose of UVB light. Serum Vitamin D and microbiome samples of each participant will be compared before and after the UVB light exposures.
Radiation: NB-UVB light exposure
Participants are exposed to three low dose Narrow Band UVB light.
- Serum vitamin D [ Time Frame: 1 week ]The effect of UVB light exposures on the serum vitamin D concentrations
- Microbiome [ Time Frame: Before and after the UVB exposures (1 week apart) ]Changes in the fecal microbiome composition after the UVB light exposures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962673
|Canada, British Columbia|
|BC Childrens Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Bruce A. Vallance, PhD||BC Childrens Hospital Research institute|