Study to Evaluate the Use of a Probiotic in SCORAD Reduct... | NCT03822624

Studies
Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis

NCT03822624

Sponsor

Biopolis S.L.

Status

Unknown status

Last Update Posted

Feb 5, 2019Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Atopic Dermatitis

Interventions

Probiotic
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2018Actual

Primary Completion Date

May 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Dec 4, 2018

First Submission Date that Met QC Criteria

Jan 28, 2019

First Posted Date

Jan 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2019

Last Update Posted Date

Feb 5, 2019Actual

Name	Class
Korott, S.L.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study's objective is to confirm that an oral probiotic treatment reduces the signs and symptoms of moderate atopic dermatitis determined by SCORAD, in patients aged 4 to 17 years, as compared to placebo. It will also be examined if the probiotic treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares, and increases the time till the first disease flare after the end of treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Label	Type	Description	Intervention Names
Probiotic group	Experimental		Dietary Supplement: Probiotic
Placebo group	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	Probiotic mixture with three bacterial strains with maltodextrin as a carrier.	Probiotic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the SCORAD index at 12 weeks.	SCORAD: SCOring of Atopic Dermatitis Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)	12-week

Secondary Outcomes

Measure	Description	Time Frame
Number of days that each patient requires the administration of topical corticosteroids.		12-week
Number of days that each patient requires the administration of topical corticosteroids in disease flares.		12-week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 4 to 17 years, both inclusive.
Diagnosed with atopic dermatitis according to Hanifin and Rajka criteria.
SCORAD index of 20-40, both inclusive.
Patients whose parents or legal guardian sign the informed consent.
The minor over 12 years must also give their consent to participate in the trial.

Exclusion Criteria:

Pregnancy.
Breast feeding.
Women of childbearing age who, in the opinion of the investigator, do not commit to using an effective method of contraception, if they have an active sex life or start during the trial.
Treated with phototherapy for the atopic dermatitis in the previous 2 months.
Treated with systemic corticosteroids in the previous 2 months or need for corticosteroids anticipated during the first 12 weeks of the study.
Having undergone cytotoxic or immunosuppressive therapy in the previous 2 months or having an anticipated need for cytotoxic or immunosuppressive therapy during the first 12 weeks of the study.
Treated with probiotics in the previous two months.
Treated with systemic antibiotics in the previous four days.
Patients with a fever (temperature > 37.5°C, axillary or equivalent).
Serious allergic diseases.
Diseases related to immunodeficiency processes or cancer.
Other skin diseases that can make assessment of the atopic dermatitis difficult or which require the continuous use of topical corticosteroids.
Patients in whom any of the study products is contraindicated according to its summary of product characteristics.
Patients who have participated in research studies with medicinal products during the previous 3 months.
Patients with gluten or lactose intolerance or inflammatory bowel disease (Crohn's disease or ulcerative colitis).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Quirónsalud San José	Recruiting	Madrid		28002	Spain
Hospital Universitario Ramón y Cajal

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena