Condition category
Skin and Connective Tissue Diseases
Date applied
06/10/2020
Date assigned
07/10/2020
Last edited
07/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Bifidobacteria are bacteria that live in the human gut. They help to improve the digestion of food and suppress the growth of harmful bacteria. Gut bacteria may also have other positive effects on human health. Bifidobacteria and components derived from Bifidobacteria have been studied for their properties in enhancing skin hydration and structure. The aim of this study is to examine the effects of taking Bifidobacterium by mouth on the skin, including hydration and moisture evaporation.

Who can participate?
Adults aged 20-65 years old with dry skin

What does the study involve?
Participants will be randomly allocated to one of two groups. Both groups will take a capsule by mouth once a day for 12 weeks. For one group, the capsule will contain Bifidobacterium. For the other, the capsule will be a dummy capsule containing no active ingredient (placebo). The capsules will look the same and neither the participants nor the researchers will know which capsule a participant is taking.

What are the possible benefits and risks of participating?
Participants may not benefit from the study as it is not known whether the test product will improve skin hydration. However, the study will extend the understanding of the effects of oral Bifidobacterium on skin hydration and skin wellbeing. As to potential risks and disadvantages due to study procedures, blood sampling may cause a hematoma or fainting, and the skin measurements and restrictions related to the measurements may cause inconvenience. The test product is not known to cause adverse effects, except a risk of possible allergy or intolerance, as for any dietary product.

Where is the study run from?
Danisco Sweeteners Oy (Finland)

When is the study starting and how long is it expected to run for?
September 2019 to December 2021

Who is funding the study?
Danisco Sweeteners Oy (Finland)

Who is the main contact?
Tuulia Vihervuori
Tuulia.vihervuori@medfiles.eu

Trial website

Contact information

Type

Public

Primary contact

Ms Tuulia Vihervuori

ORCID ID

Contact details

Rajatorpantie 41
Vantaa
FI-01640
Finland
+358 (0)40 548 7128
tuulia.vihervuori@medfiles.eu

Type

Scientific

Additional contact

Ms Laura Huuskonen

ORCID ID

Contact details

Sokeritehtaantie 20
Kantvik
FI-02460
Finland
+358 (0)40 169 4747
laura.huuskonen@dupont.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NH-10012

Study information

Scientific title

Effect of oral probiotic supplement improving skin hydration on adults during 12 weeks of intervention: a triple-blind, randomized, placebo-controlled trial

Acronym

RL_AquaProb

Study hypothesis

Consumption of probiotic enhances stratum corneum hydration in healthy adults with dry skin.

Ethics approval

Approved 25/09/2020, Ethics Committee, Hospital District of Southwest Finland (Tyks U-hospital, Kiinamyllynkatu 4-8, UB3, PO Box 52, Turku, FI-20521, Finland; +358 (0)2 313 5010, +358 (0)2 313 0047; eettinen.toimikunta(at)tyks.fi, firstname.lastname(at)tyks.fi), ref: ETMK 55/1801/2020

Study design

Randomized triple-blind parallel placebo-controlled interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dry skin

Intervention

Participants are randomly allocated to one of two treatment groups in equal proportions applying block randomization. Randomization is stratified by gender.

Participants take one daily capsule of verum (Bifidobacterium in microcrystalline cellulose) or placebo (microcrystalline cellulose) for 12 weeks with follow-up visits at 4, 8 and 12 weeks.

During the study participants will need to follow some lifestyle restrictions to allow reliable measurements of the selected skin properties. These restrictions include consumption of probiotics, use of certain topical products and harsh skin care practices (i.e. pealing of skin on areas to be measured). Also, before the visits washing of skin areas to be measured is prohibited. The study includes five visits to the study clinic. All visits will be carried out at CRST’s clinics in Turku or Helsinki, Finland.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Stratum corneum hydration measured with corneometer from check, neck and forearm from baseline to 12 weeks

Secondary outcome measures

Transepidermal water loss measured with evaporimeter from check, neck and forearm from baseline to 12 weeks

Overall trial start date

19/09/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Consent to participate in the study and willing to comply with the protocol and study restrictions
2. Females and males aged 20-65 years at randomization
3. Corneometer confirmed dry skin, arbitrary unit value under 45, measured from cheek, neck and anterior forearm. A series of 6 measurements will be taken and the middle 4 values will be used to calculate the mean value, which will be expressed in arbitrary units (a.u.). All 6 values from each location will be recorded.
4. Dry skin by self-assessment
5. Females of childbearing potential to follow a medically approved contraceptive method

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

100 (50 in test group and 50 in placebo group)

Participant exclusion criteria

1. Participation in any other clinical trial within the past 2 months before the randomization or planning to do so during the study
2. Unable or unwilling to comply with study procedures
3. Allergy or intolerance to any ingredient in the investigational products
4. Currently diagnosed with atopic dermatitis (AD)
5. Current or planned use of corticosteroids, retinoids or UV-treatment
6. Use of systemic steroids or systemic antibiotics in the 6 months before randomization
7. Use of topical corticosteroids or antibiotics prescribed by a physician or as OTC products in the 2 months before randomization
8. Wounds, scars (including severe acne scars and large burn scars) or tattoos at the skin sites to be examined in this study
9. History of any cosmetic medical treatment (such as medical chemical- or laser peelings or injections of Botox). Non-cosmetic treatment is not an exclusion criterion unless at site of measurement.
10. History of any cosmetic/beauty treatments (such as photofacial or injections of hyaluronic acid, or collagen) at the sites to be examined in this study in the past one year or intention to receive such during the study
11. Exposure to UV light treatment (such as solarium) or extensive sun bathing (i.e. skin has reacted to sun bathing) in the past two months before randomization or intention of such during the study
12. Screening hematology, serum and urinary laboratory analyses results that are deemed clinically significantly abnormal by the investigator
13. Pregnant or breastfeeding or planning pregnancy during the study
14. Otherwise considered unsuitable for the study by the principal investigator

Recruitment start date

15/10/2020

Recruitment end date

18/12/2020

Locations

Countries of recruitment

Finland

Trial participating centre

CRST Oy
Itäinen Pitkäkatu 4 B, 3rd floor/3.krs
Turku
FI-20520
Finland

Trial participating centre

CRST Oy
Energiakatu 4
Helsinki
FI-00180
Finland

Sponsor information

Organisation

Danisco Sweeteners Oy

Sponsor details

Sokeritehtaantie 20
Kantvik
FI-02460
Finland
+358 (0)40 167 8509
alvin.ibarra@dupont.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Danisco Sweeteners Oy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The full study protocol and statistical analysis plan won’t be available, but the study methods and statistical analyses will be reported in the publication in detail.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to the investigational product being a food supplement, thus no regulatory obligation requests to supply participant-level data.

Intention to publish date

31/12/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/10/2020: Trial's existence confirmed by the Ethics Committee of the Hospital District of Southwest Finland.