UVB: Skin to Gut Study

Healthy Clinical Trial

Official title:

Intestinal Microbiota Changes After Ultra Violet Radiation B Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962673
• Other study ID #: H17-00303
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: February 26, 2019

Study information

• Verified date: May 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinal microbiota composition and confirm a regulatory skin-to-gut axis during baseline conditions. Changes in the intestinal microbiota composition caused by NB-UVB phototherapy could be beneficial for patients with chronic/auto-inflammatory diseases like inflammatory bowel disease (IBD) by removing dangerous bacteria, increasing beneficial bacteria, and ultimately modulating immune responses.

Description:

Purpose:

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.

Hypothesis:

Humans exposed to UVB-NB light will show changes in the intestinal microbiota composition with the selection of certain phyla of bacteria.

Justification:

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.

Objectives:

1. Establish if there is a skin regulatory response towards NB-UVB light in humans.

2. Examine what changes in the microbiota composition can be observed on bacterial phyla and class level.

3. Determine if this research is worth pursuing in a larger cohort.

Research design:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 26, 2019
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy Caucasian females

• Fitzpatrick skin type I, II or III

Exclusion Criteria:

• Skin photosensitivity due to medication

• Been on vacation to a sunny destination three months before enrollment

• Visit tanning beds on a regular basis in the past

Related Conditions & MeSH terms

• Healthy

Intervention

Radiation:
• NB-UVB light exposure
Participants are exposed to three low dose Narrow Band UVB light.

Locations

Country	Name	City	State
Canada	BC Childrens Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum vitamin D	The effect of UVB light exposures on the serum vitamin D concentrations	1 week
Primary	Microbiome	Changes in the fecal microbiome composition after the UVB light exposures	Before and after the UVB exposures (1 week apart)