Atopic DermatitisNCT03822624
Study to Evaluate the Use of a Probiotic in SCORAD Reduction in Young Patients With Atopic Dermatitis
A study testing Probiotic in people with Atopic Dermatitis, run by Biopolis S.L. at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesSpain
- Study dates
- 23 May 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Quirónsalud San José
Madrid, 28002
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
- Recruiting
Hospital Vithas Nisa 9 de Octubre
Valencia, 46015
About this study
Official title: Randomized, Double Blind, Placebo Controlled Study to Evaluate Efficiency and Safety on the Use of a Probiotic in SCORAD Reduction in 4-to-17 Years-old Patients With Atopic Dermatitis
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
PlaceboOther
Placebo comparator with maltodextrin as a carrier.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Not described Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12-week
Secondary outcomes (8)
Number of days that each patient requires the administration of topical corticosteroids.
Measured: 12-week
Number of days that each patient requires the administration of topical corticosteroids in disease flares.
Measured: 12-week
Total dose of topical corticosteroids.
Measured: 12-week
Number of patients who reach a CGI score lower than 2.
CGI: Clinical Global Impression
Total: 0 - 5 (Higher values represent a worse outcome)
Measured: 12-week
Number of adverse events.
Measured: 12-week
Use of antihistamines and other treatments.
Measured: 12-week
Adherence to the treatment.
Percentage of treatment intake days.
Measured: 12-week
Disease-free time up to 24 weeks.
Measured: 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start23 May 2018
- Primary completionMay 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopolis S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korott, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822624
- Sponsor's protocol ID
- ATOP/PRO-2
- Status last verified
- Feb 2019
- First submitted
- 4 Dec 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Study to Evaluate Efficiency and Safety on the Use of a Probiotic in SCORAD Reduction in 4-to-17 Years-old Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03822624
- Acronym / sponsor ID
- ATOP/PRO-2
- Conditions
- Atopic Dermatitis
- Keywords
- Probiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Biopolis S.L.Industry (pharma, biotech, devices)
- Collaborators
- Korott, S.L.
- Study start
- 23 May 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticProbiotic mixture with three bacterial strains with maltodextrin as a carrier. | Dietary supplement | Probiotic group |
| PlaceboPlacebo comparator with maltodextrin as a carrier. | Other | Placebo group |
Primary outcome
Change from baseline in the SCORAD index at 12 weeks.
Time frame: 12-week
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)
8 secondary outcomes
Number of days that each patient requires the administration of topical corticosteroids.
Time frame: 12-week
Number of days that each patient requires the administration of topical corticosteroids in disease flares.
Time frame: 12-week
Total dose of topical corticosteroids.
Time frame: 12-week
Number of patients who reach a CGI score lower than 2.
Time frame: 12-week
Number of adverse events.
Time frame: 12-week
Use of antihistamines and other treatments.
Time frame: 12-week
Adherence to the treatment.
Time frame: 12-week
Disease-free time up to 24 weeks.
Time frame: 24-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Atopic Dermatitis, run by Biopolis S.L. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Empar Chenoll, PhD (625851114, maria.chenoll@adm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the SCORAD index at 12 weeks. (time frame: 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.