Psoriasis VulgarisPhase 1/2NCT05254249
Clinical Trial of Probiotic Supplementation in Psoriasis Vulgaris
A Phase 1/2 study testing Lactobacillus Plantarum IS-10506 in people with Psoriasis Vulgaris, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Lactobacillus Plantarum IS-10506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Feb 2022to Oct 2022
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Group Inclusion Criteria:
- Psoriasis vulgaris patients with or without treatment
- Mild to moderate degree
- Age 18-70 years old
- Willing to give informed consent
- Healthy Control Group Inclusion Criteria:
Show all 10Show fewer
- Undiagnosed as Psoriasis
- Body mass index (BMI) is matched with the patient group
- Age 18-70 years old
- Willing to give Informed Consent
Who cannot join
- Patient Group Exclusion Criteria:
- Patients on systemic treatment with corticosteroids, methotrexate, cyclosporine, or biologic agents within 3 months prior to sampling
- Take oral antibiotics, laxatives, and proton pump inhibitors (PPI) within 14 days before stool sampling
- Suffering from severe systemic disease, diarrhea
- Pustular psoriasis patients
- Take probiotics within 30 days before stool sampling
Show all 10Show fewer
- Healthy Control Group Exclusion Criteria:
- Patients on systemic treatment with corticosteroids, methotrexate, cyclosporine, or biologic agents within 3 months before stool sampling
- Take oral antibiotics, laxatives, and proton pump inhibitors (PPI) within 14 days before stool sampling
- Suffering from severe systemic disease, diarrhea
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Universitas Airlangga
Surabaya, East Java
Menul Ayu Umborowati, +628132885950, menulayu@gmail.com
About this study
Official title: Analysis of Gut Microbiota, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor -α, Interleukin-10, and Foxp3 in Psoriasis Vulgaris After Supplementation With Lactobacillus Plantarum IS-10506
Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs.
The provision of probiotic Lactobacillus plantarum IS-10506, an Indonesian original probiotic strain, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia.
This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.
Read the detailed description
Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. Psoriasis can increase the incidence of other diseases such as joint disorders, cardiovascular disorders, and psychological. Symptoms of psoriasis on the skin are red, well-defined plaques covered with thick, white, layered scales. The incidence of psoriasis is quite large, known to affect 0.09 - 11.4% of the world's population with rates varying between regions. Data in Indonesia is estimated that there are 2-6 million psoriasis sufferers in 2010, with a prevalence range of 1-3% in several teaching hospitals. During the period from 2016 to 2018, psoriasis vulgaris patients in the outpatient unit of RSUD Dr. Soetomo Surabaya recorded as many as 208 or 0.46% of all skin patients.
One of the mechanisms of psoriasis is abnormalities in Treg cells (cells that play a role in expressing Foxp3), resulting in an imbalance in the immune system with the dominance of T helper 1 (Th1) and T helper 17 (Th17) cells. In addition, the composition of the gut microbiota (collection of bacteria) in psoriasis patients is different from that of healthy people. The composition of the gut microbiota can be influenced by race, geography, and eating habits. Until now there has been no report on the intestinal microbiota profile of psoriasis patients in Indonesia.
The provision of probiotic Lactobacillus plantarum IS-10506, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. Lactobacillus plantarum IS-10506 is produced from Dadih, a traditional fermented milk from West Sumatra, Indonesia. This probiotic is expected to be most compatible with the composition of the gut microbiota of Indonesians because it comes from an environment with similar exposure to pathogenic bacteria.
This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Lactobacillus Plantarum IS-10506, Placebo
- Keywords
- Psoriasis Vulgaris, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor- A, Interleukin-10, Foxp3, Lactobacillus Plantarum IS-10506, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Plantarum IS-10506Drug
Also called Probiotic
Indonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU
PlaceboOther
Placebo is an empty drug, given in capsule form with a dose of 2x1 sachets
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | In the treatment group, intervention was given in the form of standard therapy and probiotic Lactobacillus plantarum IS 10605 in the amount of 2x1010 CFU for 12 weeks. Receives: Drug: Lactobacillus Plantarum IS-10506 |
| Placebo Group | Placebo comparator | In the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks. Receives: Other: Placebo |
| Healty Control Group | No intervention | Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha and beta
Alpha and beta diversity in gut microbiota profiles
Measured: 12 weeks
Serum levels
Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method
Measured: 12 weeks
PASI scores
Changes in PASI scores after the intervention
Measured: 12 weeks
Secondary outcomes (1)
DLQI
Changes in the score of impaired quality of life due to skin diseases experienced using the DLQI questionnaires
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start7 Feb 2022
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Collaborators
- Universitas Airlangga
- Responsible party
- Principal investigator, Menul Ayu Umborowati, dr., Sp.KK, Dr. Soetomo General Hospital
- Investigators
- Menul Ayu Umborowati, Specialist, Study chair, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254249
- Sponsor's protocol ID
- 0315/KEPK/XI/2021
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 24 Feb 2022
- 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 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gut Microbiota, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor -α, Interleukin-10, and Foxp3 in Psoriasis Vulgaris After Supplementation With Lactobacillus Plantarum IS-10506
- ClinicalTrials.gov ID
- NCT05254249
- Acronym / sponsor ID
- 0315/KEPK/XI/2021
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis Vulgaris, Psoriasis Area and Severity Index, Interleukin-17, Tumor Necrosis Factor- A, Interleukin-10, Foxp3, Lactobacillus Plantarum IS-10506, Gut Microbiota
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Collaborators
- Universitas Airlangga
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 24 Feb 2022 (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.
Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs.
The provision of probiotic Lactobacillus plantarum IS-10506, an Indonesian original probiotic strain, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia.
This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.
Detailed description
Psoriasis is a chronic inflammatory skin disease (chronic and recurrent) which is influenced by various factors, namely genetics, immunological processes, and environmental triggers such as infection, obesity, smoking, and drugs. Psoriasis can increase the incidence of other diseases such as joint disorders, cardiovascular disorders, and psychological. Symptoms of psoriasis on the skin are red, well-defined plaques covered with thick, white, layered scales. The incidence of psoriasis is quite large, known to affect 0.09 - 11.4% of the world's population with rates varying between regions. Data in Indonesia is estimated that there are 2-6 million psoriasis sufferers in 2010, with a prevalence range of 1-3% in several teaching hospitals. During the period from 2016 to 2018, psoriasis vulgaris patients in the outpatient unit of RSUD Dr. Soetomo Surabaya recorded as many as 208 or 0.46% of all skin patients.
One of the mechanisms of psoriasis is abnormalities in Treg cells (cells that play a role in expressing Foxp3), resulting in an imbalance in the immune system with the dominance of T helper 1 (Th1) and T helper 17 (Th17) cells. In addition, the composition of the gut microbiota (collection of bacteria) in psoriasis patients is different from that of healthy people. The composition of the gut microbiota can be influenced by race, geography, and eating habits. Until now there has been no report on the intestinal microbiota profile of psoriasis patients in Indonesia.
The provision of probiotic Lactobacillus plantarum IS-10506, is expected to be an effective, safe, and affordable alternative for psoriasis treatment for psoriasis patients in Indonesia. Lactobacillus plantarum IS-10506 is produced from Dadih, a traditional fermented milk from West Sumatra, Indonesia. This probiotic is expected to be most compatible with the composition of the gut microbiota of Indonesians because it comes from an environment with similar exposure to pathogenic bacteria.
This study aimed to evaluate changes in gut microbiota profile, cytokines IL-17, TNF-a, IL-10, Foxp3, and disease severity of psoriasis vulgaris patients after supplementation with Lactobacillus plantarum IS-10506. The results of this study are expected to be the basis for the use of Lactobacillus plantarum IS-10506 in the therapy of psoriasis vulgaris which is included in the Clinical Practice Guide in Indonesia, which will ultimately help improve the quality of life of psoriasis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A double blinded randomized clinical trial using a prospective cohort method in psoriasis vulgaris patients with purposive sampling.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Lactobacillus Plantarum IS-10506In the treatment group, intervention was given in the form of standard therapy and probiotic Lactobacillus plantarum IS 10605 in the amount of 2x1010 CFU for 12 weeks. |
| Placebo Group | Placebo comparator | Other: PlaceboIn the placebo group, intervention was given in the form of standard therapy and placebo 2x1 sachets for 12 weeks. |
| Healty Control Group | No intervention | –Healthy control group was not given any treatment. Stool samples were taken to examine the gut microbiota profile. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Psoriasis vulgaris patients with or without treatment
- Mild to moderate degree
- Age 18-70 years old
- Willing to give informed consent
- Undiagnosed as Psoriasis
Key exclusion criteria (10 listed)
- Patients on systemic treatment with corticosteroids, methotrexate, cyclosporine, or biologic agents within 3 months prior to sampling
- Take oral antibiotics, laxatives, and proton pump inhibitors (PPI) within 14 days before stool sampling
- Suffering from severe systemic disease, diarrhea
- Pustular psoriasis patients
- Take probiotics within 30 days before stool sampling
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 |
|---|---|---|
| Lactobacillus Plantarum IS-10506Also: ProbioticIndonesian original probiotic, given in capsule form with a dose of 2 x 1010 CFU | Drug | Treatment Group |
| PlaceboPlacebo is an empty drug, given in capsule form with a dose of 2x1 sachets | Other | Placebo Group |
Primary outcome
Alpha and beta
Time frame: 12 weeks
Alpha and beta diversity in gut microbiota profiles
Serum levels
Time frame: 12 weeks
Changes in serum levels of TNF-α, IL-17, IL-10, and Foxp3 by ELISA method
PASI scores
Time frame: 12 weeks
Changes in PASI scores after the intervention
1 secondary outcome
DLQI
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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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.
Menul Ayu Umborowati, Specialist study chair
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus Plantarum IS-10506 in people with Psoriasis Vulgaris, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 10 inclusion and 10 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 24 Feb 2022. 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 Indonesia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Menul Ayu Umborowati, Specialist (+6281328859509, menulayu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha and beta (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 24 Feb 2022.