Condition category
Skin and Connective Tissue Diseases
Date applied
02/03/2020
Date assigned
05/03/2020
Last edited
06/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Atopic Dermatitis (AD) is an inflammatory, chronic, pruritic skin disease with a large scale of severity, and a high rate of recurrence and infections due to scarring, which can really affect health-related quality of life. AD related symptoms are itching, redness, dry & scaly skin and recurrent eczematous lesions. Almost 60% of the world population, especially children, suffers from AD.
AD development is characterized by external stimuli (allergens), immune mechanisms (inflammatory cytokines) and alteration of gut and skin microbial community. The correlation between skin and intestine, the so-called gut–skin axis, relies on the concept that gut unbalances can affect skin by inducing systemic inflammation and by triggering dermatological diseases like AD. Conversely, the gut microbiome can strongly influence the host immune system providing protection against pathogens and triggering an immune protective response. So, modulation of gut microbiome in order to achieve a positive effect on the skin provides a safe and innovative approach to skin diseases. Probiotics administration represents a well-recognized approach to modulate gut microbiome, and as referring to AD, several studies pointed at such treatment to ameliorate AD conditions and to prevent recurrences.
The aim of the clinical study is to evaluate the efficacy of a treatment with a food supplement containing a mixture of probiotics (Lactobacillus plantarum, Lactobacillus reuteri and Lactobacillus rhamnosus), specifically selected in terms of post-biotic metabolites and B-group vitamins production, anti-inflammatory and anti-oxidant capacity and anti-microbial activity against skin pathogens, in ameliorating AD symptoms and improving the skin conditions, furthermore the effect of such probiotic mixture on the expression inflammatory markers in skin tape stripping was investigated.

Who can participate?
Healthy adult volunteers, 20 to 50 years old, with a mild-moderate score of Atopic Dermatitis by SCORAD

What does the study involve?
Participants will be randomly allocated to take one capsule a day of the food supplement or the placebo with a glass of water, away from meals, for 56 days. AD symptoms and skin parameters will be analyzed at the enrollment (T0d), during products intake (T28d and T56d), and after a follow-up of 28 days without taking products (T84d); anti-inflammatory parameters will be measured on skin tape stripping sampled at T0d T28d, and T56d.

What are the possible benefits and risks of participating?
Benefits associated with products use are amelioration of AD symptoms and skin conditions.
Risks associated with the intake of the products are considered from low to very low, in absence of allergy/intolerances to product ingredients; other ingredients in the formula of the product are commonly used in dietary supplements. All the instrumental measurements carried out are not invasive and no skin side effects are expected from the measurement process.

Where is the study run from?
Complife Italia Srl (Italy)

When is the study starting and how long is it expected to run for?
October 2018 to April 2019

Who is funding the study
Regione Lombardia (Italy)

Who is the main contact
Dr. Francesco Tursi
francesco.tursi@complifegroup.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco Tursi

ORCID ID

http://orcid.org/0000-0002-0055-5925

Contact details

COMPLIFE ITALIA Srl
Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
+39 (0)2 99025138
francesco.tursi@complifegroup.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

E.HU.027-0080.05.004L_2018/2278

Study information

Scientific title

Efficacy of a probiotic supplement in improving atopic dermatitis symptoms. A randomized double blind placebo controlled clinical trial

Acronym

Study hypothesis

The administration of a food supplement containing selected probiotic strains ameliorates atopic dermatitis symptoms

Ethics approval

Approved 04/09/2018, Independent Ethical Committee for Non-Pharmacological Clinical Study Trials (Via XX Settembre 30/4, 16121Genova, Italy; +39(0)10 5454842; a.scudieri@studinonfarmacologici.it), ref: 2018/09

Study design

Single-centre randomized double-blind placebo-controlled parallel-group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atopic dermatitis

Intervention

Subjects aged between 18 and 50 years showing a mild-moderate score of atopic dermatitis (AD) diagnosed by SCORAD, will be equally randomized in two groups to receive one capsule/day of food supplement or placebo for a period of 56 days and will be followed up for a further period of 28 days from the last ingestion of the capsules.

A restricted randomization list was generated by the in-site Study Director using an appropriate statistic algorithm (“Wey’s urn”). Randomization list and envelope containing information on the products were stored by the in-site Study Director, under appropriate safety conditions in a place that is not accessible neither to volunteers nor to the experimenter.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

1. Clinical assessment of the SCORAD Index evaluated by a dermatologist at the beginning of the study (T0d), throughout the intake of the products (T28d and T56d) and 4 weeks after the intake of the products (T84d)
2. Clinical assessment of Skin smoothness evaluated by a dermatologist at the beginning of the study (T0d), throughout the intake of the products (T28d and T56d) and 4 weeks after the intake of the products (T84d)
3. Determination of the Skin moisturization evaluated as Skin Moisturization Index (Corneometer method) and Trans Epidermal Water Loss (TEWL) at the beginning of the study (T0d), throughout the intake of the products (T28d and T56d) and 4 weeks after the intake of the products (T84d)
4. Cytokine expression such as TNFα (general), TARC (Thymus and activated-regulated chemokine) and TSLP (Thymic Stromal Lymphopoietin) measured by ELISA on skin tape stripping sampled at the beginning of the study (T0d) and throughout the intake of the products (T28d and T56d)

Secondary outcome measures

1. Relief from skin discomfort evaluated using a self-assessment questionnaire administered at the end of treatment (T56d) and after the follow-up period (T84d)
2. Quality of life evaluated using a self-assessment questionnaire administered at the end of treatment (T56d) and after the follow-up period (T84d)

Overall trial start date

28/03/2018

Overall trial end date

19/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-50 years, with Phototype I to IV
2. Mild to moderate SCORAD (between 15 and 25)
3. Willingness to use during all the study period only the products to be tested
4. Subjects who have not been recently involved in any other similar study
5. Willingness to not use products likely to interfere with the products to be tested
6. Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, etc.)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Current antibiotic administration
2. Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
3. Treatment with probiotics in the 6 months preceding enrollment
4. Treatment with steroids and antihistamines systemically in the three months prior to enrollment
5. Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrollment
6. Acute or chronic infectious diseases
7. Subjects who has used sun-beds or self-tanning product for one month before the study or intend to use it during the present study

Recruitment start date

08/10/2018

Recruitment end date

23/11/2018

Locations

Countries of recruitment

Italy

Trial participating centre

Complife Italia Srl
Via Mons. Angelini 21
San Martino Siccomario (PV)
27028
Italy

Sponsor information

Organisation

Complife Italia Srl

Sponsor details

Via Guido Rossa 1
Garbagnate Milanese
20024
Italy
+39 (0)299025138
info@complifegroup.com

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

Regione Lombardia

Alternative name(s)

Lombardy Region, Region of Lombardy

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Results and Publications

Publication and dissemination plan

A paper will be published in relevant international peer-reviewed journals such as European Journal of Dermatology.

IPD sharing statement:
Raw data will be stored in Complife servers. A backup copy of the raw data will be also in a cloud-based backup server. Tables containing the raw data (output of the measurements) will be also included in the study report and shared with the study Sponsor by a pdf file electronically
signed. The raw data will be stored for a minimum period of 10 years in Complife servers. In the raw data tables, subjects are identified by a means of a code generated by the Complife volunteer’s management software. The code is composed of a letter, 4 digits, and a letter. The
access to the study raw data is allowed only to the study director and the person designated by him to elaborate the raw data. Elaboration of the raw data includes descriptive statistics (mean and standard error) and the inferential analysis (data normality and statistical test).

Intention to publish date

30/04/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/03/2020: Uploaded protocol version 1.0 06 July 2018 (not peer reviewed). 04/03/2020: Trial’s existence confirmed by Independent Ethical Committee for Non-Pharmacological Clinical Study Trials (Genova, Italy)