UVB: Skin to Gut Study
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03962673 |
|
Recruitment Status :
Completed
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Radiation: NB-UVB light exposure | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 23 participants |
| 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 |
| 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. |
- Serum vitamin D [ Time Frame: 1 week ]The effect of UVB light exposures on the serum vitamin D concentrations
- Microbiome [ Time Frame: Before and after the UVB exposures (1 week apart) ]Changes in the fecal microbiome composition after the UVB light exposures
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962673
| Canada, British Columbia | |
| BC Childrens Hospital | |
| Vancouver, British Columbia, Canada, V6H 3N1 | |
| Principal Investigator: | Bruce A. Vallance, PhD | BC Childrens Hospital Research institute |
Documents provided by Bruce Vallance, University of British Columbia:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| 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 |
|
Phototherapy Microbiome Vitamin D |