NCT03962673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

May 22, 2019

Last Update Submit

May 23, 2019

Conditions

Keywords

PhototherapyMicrobiomeVitamin D

Outcome Measures

Primary Outcomes (2)

  • Serum vitamin D

    The effect of UVB light exposures on the serum vitamin D concentrations

    1 week

  • Microbiome

    Changes in the fecal microbiome composition after the UVB light exposures

    Before and after the UVB exposures (1 week apart)

Study Arms (1)

UVB- exposure

EXPERIMENTAL

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

Interventions

Participants are exposed to three low dose Narrow Band UVB light.

UVB- exposure

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy Caucasian females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Caucasian females
  • Fitzpatrick skin type I, II or III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Childrens Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

  • 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.

Study Officials

  • Bruce A. Vallance, PhD

    BC Childrens Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants are receiving the same treatment of which the UVB dose is adjusted for the participants Fitzpatrick skin type.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 24, 2019

Study Start

February 19, 2018

Primary Completion

April 27, 2018

Study Completion

February 26, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Participant information remains deidentified.

Locations