UVB: Skin to Gut Study

• ClinicalTrials.gov Identifier: NCT03962673
• Recruitment Status: Completed
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Bruce Vallance, University of British Columbia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Radiation: NB-UVB light exposure	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Serum vitamin D [ Time Frame: 1 week ]
   The effect of UVB light exposures on the serum vitamin D concentrations
2. Microbiome [ Time Frame: Before and after the UVB exposures (1 week apart) ]
   Changes in the fecal microbiome composition after the UVB light exposures

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Healthy Caucasian females
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Canada, British Columbia

BC Childrens Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: Bruce A. Vallance, PhD; BC Childrens Hospital Research institute

  Study Documents (Full-Text)

Documents provided by Bruce Vallance, University of British Columbia:

Study Protocol and Statistical Analysis Plan  [PDF] February 12, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bosman ES, Albert AY, Lui H, Dutz JP, Vallance BA. Skin Exposure to Narrow Band Ultraviolet (UVB) Light Modulates the Human Intestinal Microbiome. Front Microbiol. 2019 Oct 24;10:2410. doi: 10.3389/fmicb.2019.02410. eCollection 2019.

• Responsible Party: Bruce Vallance, Principle Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT03962673
• Other Study ID Numbers: H17-00303
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Participant information remains deidentified.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bruce Vallance, University of British Columbia:

Phototherapy; Microbiome; Vitamin D