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Completed

NCT Number: NCT03962673

UVB: Skin to Gut Study

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.

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Key information

Conditions

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Childrens Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NB-UVB light exposure

Radiation

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Intestinal Microbiota Changes After Ultra Violet Radiation B Exposure

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 24, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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