UVB: Skin to Gut Study

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT03962673

Collaborator

(none)

Enrollment

Location

Arm

12.2

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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	N/A

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:

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.

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

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.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 :

Feb 19, 2018

Actual Primary Completion Date :

Apr 27, 2018

Actual Study Completion Date :

Feb 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.

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	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)

Study Protocol and Statistical Analysis Plan - Feb 12, 2019

More Information

Publications

None provided.

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 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bruce Vallance, Principle Investigator, University of British Columbia

Phototherapy

Microbiome

Vitamin D

Study Results

No Results Posted as of May 24, 2019