Status:
UNKNOWN
Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis
Lead Sponsor:
Biopolis S.L.
Collaborating Sponsors:
Korott, S.L.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
4-17 years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03822624
Start Date
May 23 2018
End Date
September 1 2019
Last Update
February 5 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Quirónsalud San José
Madrid, Spain, 28002
2
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
3
Hospital Vithas Nisa 9 de Octubre
Valencia, Spain, 46015