PsoriasisNCT02576197
Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis Patients
A study testing Probiotic in people with Psoriasis, run by Biopolis S.L. at 1 site in Spain.
Trial summary
This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Sep 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plaque psoriasis diagnosed at least a year before the beginning of the treatment.
- Mild to moderate Psoriasis with a PASI score higher than 6 with no new flare-up in the previous four week to the beginning of the treatment.
- Patients capable of giving their informed consent to their participation in the study
- For women in fertile age, a negative pregnancy test before the beginning of the treatment, and the use of active contraceptive methods is required
Who cannot join
- Patients suffering from Crohn disease, hepatic cirrhosis, morbid obesity, VIH-positive or any other active infection.
- The use of any systemic, oral or parenteral psoriasis treatment in the last three months.
- The use of any antibiotic, probiotic or/and prebiotic in the last two weeks.
- The use of natural product with proved efficiency on health (apart from multivitamin and multimineral products)
- Any hepatic, renal, endocrine, respiratory, neurologic or cardiovascular disease.
- Pregnancy and breastfeeding.
- Patients not being capable of giving their informed consent or not being capable of following the study conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Placebo-Controlled Intervention Study to Evaluate the Effectiveness and Safety of a Treatment With a Probiotic in Adult Patients Diagnosed With Mild to Moderate Plaque Psoriasis
This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment.
Read the detailed description
The aim of this study is to evaluate the efficiency of a probiotic in capsules as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. The efficiency is measured as the reduction in the PASI score in the patients (18 to 70 years old) included in the study, with a mild to moderate plaque psoriasis treated exclusively with topic treatment in the moment of being included in the study. Apart from the PASI score reduction from the first visit to the end of the study, the ability to reduce the improvement time in those patients will be evaluated as well. Additionally, the following markers of systemic inflammation are also compared between both active and placebo branches: Tumor necrosis factor, Interferon-gamma, interleukines 1b, 12, 16 and 23.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)
PlaceboDietary supplement
one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments) Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a PASI score reduction higher than 75%
Number of patients with a PASI score reduction higher than 75% from the basal value
Measured: twelve weeks
Time to reach a reduction in the PASI score higher than 75%
time to reach a reduction in the PASI score higher than 75% in from the basal value
Measured: twelve weeks
Secondary outcomes (5)
Average time to reach the clinical remission
Average time to reach the clinical remission, with no activity (PASI score lower than 6) from the treatment beginning
Measured: twelve weeks
Differences among any of the inflammation markers
Measured: twelve weeks
number of patients that remains in analytical remission
number of patients that remains in analytical remission (that is, that maintain said inflammation markers in normal values)
Measured: twelve weeks
Number of patients with mild, moderate or severe adverse events
Number of patients with mild, moderate or severe adverse events attributable to regular treatment to psoriasis or to probiotic.
Measured: twelve weeks
Number of patients with an improvement in the PGA score
Number of patients with an improvement in the PGA score at the end of the study with regard of basal values
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biopolis S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korott, S.L.
- Responsible party
- Sponsor
- Investigators
- Vicente Navarro-López, MD, Principal investigator, Universidad Católica San Antonio de MurciaAna A Ramirez-Boscá, MD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576197
- Sponsor's protocol ID
- PSO/PRO 2
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ramirez-Bosca A, Navarro-Lopez V, Martinez-Andres A, Such J, Frances R, Horga de la Parte J, Asin-Llorca M. Identification of Bacterial DNA in the Peripheral Blood of Patients With Active Psoriasis. JAMA Dermatol. 2015 Jun;151(6):670-1. doi: 10.1001/jamadermatol.2014.5585. No abstract available.
PubMed 25760018Betsi GI, Papadavid E, Falagas ME. Probiotics for the treatment or prevention of atopic dermatitis: a review of the evidence from randomized controlled trials. Am J Clin Dermatol. 2008;9(2):93-103. doi: 10.2165/00128071-200809020-00002.
PubMed 18284263
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-Controlled Intervention Study to Evaluate the Effectiveness and Safety of a Treatment With a Probiotic in Adult Patients Diagnosed With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02576197
- Acronym / sponsor ID
- PSO/PRO 2
- Conditions
- Psoriasis
- Keywords
- mild to moderate, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Biopolis S.L.Industry (pharma, biotech, devices)
- Collaborators
- Korott, S.L.
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment.
Detailed description
The aim of this study is to evaluate the efficiency of a probiotic in capsules as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. The efficiency is measured as the reduction in the PASI score in the patients (18 to 70 years old) included in the study, with a mild to moderate plaque psoriasis treated exclusively with topic treatment in the moment of being included in the study. Apart from the PASI score reduction from the first visit to the end of the study, the ability to reduce the improvement time in those patients will be evaluated as well. Additionally, the following markers of systemic inflammation are also compared between both active and placebo branches: Tumor necrosis factor, Interferon-gamma, interleukines 1b, 12, 16 and 23.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probioticone capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments) |
| Placebo | Placebo comparator | Dietary Supplement: Placeboone capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Plaque psoriasis diagnosed at least a year before the beginning of the treatment.
- Mild to moderate Psoriasis with a PASI score higher than 6 with no new flare-up in the previous four week to the beginning of the treatment.
- Patients capable of giving their informed consent to their participation in the study
- For women in fertile age, a negative pregnancy test before the beginning of the treatment, and the use of active contraceptive methods is required
Key exclusion criteria (7 listed)
- Patients suffering from Crohn disease, hepatic cirrhosis, morbid obesity, VIH-positive or any other active infection.
- The use of any systemic, oral or parenteral psoriasis treatment in the last three months.
- The use of any antibiotic, probiotic or/and prebiotic in the last two weeks.
- The use of natural product with proved efficiency on health (apart from multivitamin and multimineral products)
- Any hepatic, renal, endocrine, respiratory, neurologic or cardiovascular disease.
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 |
|---|---|---|
| Probioticone capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments) | Dietary supplement | Probiotic |
| Placeboone capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments) | Dietary supplement | Placebo |
Primary outcome
Number of patients with a PASI score reduction higher than 75%
Time frame: twelve weeks
Number of patients with a PASI score reduction higher than 75% from the basal value
Time to reach a reduction in the PASI score higher than 75%
Time frame: twelve weeks
time to reach a reduction in the PASI score higher than 75% in from the basal value
5 secondary outcomes
Average time to reach the clinical remission
Time frame: twelve weeks
Differences among any of the inflammation markers
Time frame: twelve weeks
number of patients that remains in analytical remission
Time frame: twelve weeks
Number of patients with mild, moderate or severe adverse events
Time frame: twelve weeks
Number of patients with an improvement in the PGA score
Time frame: Twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 25760018Ramirez-Bosca A, Navarro-Lopez V, Martinez-Andres A, Such J, Frances R, Horga de la Parte J, Asin-Llorca M. Identification of Bacterial DNA in the Peripheral Blood of Patients With Active Psoriasis. JAMA Dermatol. 2015 Jun;151(6):670-1. doi: 10.1001/jamadermatol.2014.5585. No abstract available.
- Background: PubMed 18284263Betsi GI, Papadavid E, Falagas ME. Probiotics for the treatment or prevention of atopic dermatitis: a review of the evidence from randomized controlled trials. Am J Clin Dermatol. 2008;9(2):93-103. doi: 10.2165/00128071-200809020-00002.
- Individual participant dataSharing planned: No
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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.
Vicente Navarro-López, MD principal investigator
Universidad Católica San Antonio de Murcia
Ana A Ramirez-Boscá, MD principal investigator
Universidad Católica San Antonio de Murcia
1 site 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 Psoriasis, run by Biopolis S.L. at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a PASI score reduction higher than 75% (time frame: twelve weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576197, which also lists 2 linked publications.
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 18 Oct 2016.