Psoriasis (PsO)Early Phase 1NCT07169019
Microbiome and Clinical Response to Probiotics and Methotrexate in Early Psoriasis: a Pilot Study
A Early Phase 1 study testing Probiotics and methotrexate and Methotrexate in people with Psoriasis (PsO), run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if probiotics work to improve the response of psoriatic patients to methotrexate treatment in adults. It will also learn about the beneficial effect of probiotics on the gut microbiota of psoriatic patients treated with methotrexate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO)
- What is being tested?
- Probiotics and methotrexate and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with chronic plaque psoriasis.
Who cannot join
- • Psoriatic patients who used systemic treatments at least 3 months before the study, with the exception of acetritin use, in the last 3 years.
- Patients who have skin infection or other skin or autoimmune diseases such as SLE, Lichen planus, Dermatomyositis and Vitiligo, by history and examination.
- Pregnant or Lactating mothers.
- Patients with any contraindication to methotrexate treatment.
- Patients who develop any adverse reaction during systemic treatment with methotrexate that necessitates cessation of treatment before the 16th week, such as bone marrow suppression as indicated by CBC, elevated liver enzymes, or severe GIT upset.
- Patients with low intellectual capacity, uneducated patients, or patients unable or unwilling to provide daily feedback about their compliance to the provided probiotics treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Medical Research Institute, Alexandria University
Alexandria, 21561
Aliaa G. Aboulela, PhD, +201002104138, aliaagamaleldin@alexu.edu.eg
Eman M. Eleryan., MD., +201001538935, eman.elaryan@alexmed.edu.eg
About this study
Official title: Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study
The goal of this clinical trial is to learn if probiotics work to improve the response of psoriatic patients to methotrexate treatment in adults. It will also learn about the beneficial effect of probiotics on the gut microbiota of psoriatic patients treated with methotrexate. The main questions it aims to answer are:
Do probiotics enhance the reduction of disease burden in psoriatic patients under methotrexate treatment? Do probiotics increase the beneficial gut bacteria and decrease the harmful gut bacteria in psoriatic patients under methotrexate treatment? Researchers will compare probiotics intake along with methotrexate to methotrexate alone to see if probiotics work to enhance the reduction of the severity of psoriasis in patients treated by methotrexate and whether the addition of probiotics will improve their gut health.
Read more
Participants will:
Take a daily dose of probiotics with a weekly dose of methotrexate or only a weekly dose of methotrexate for 4 months.
Give daily feedback to the researchers about their probiotic intake and their dietary intake.
Visit the clinic after 1 and 2 weeks of beginning treatment and then once every 4 weeks for checkups and tests.
Read the detailed description
This study aims to identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard first line treatment with methotrexate alone.
Methods
- Collection of demographic and clinical data:
- Data about the full medical history will be collected for all patients (including name, age, sex, history of the disease, duration of illness, association with other autoimmune diseases like vitiligo, diabetes type 1, etc).
- Data about the results of full clinical examination of all patients will be collected.
- Data about the clinical assessment of the severity of Psoriasis will be collected as indicated by the Psoriasis Activity and Severity Index (PASI) score (which is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance). PASI score will be calculated before treatment and every month during treatment. (Appendix 1)
- Data about base line pretreatment laboratory investigations will be collected: CBC, liver and renal function test.
- Data about follow up lab investigations will be collected:
- CBC at week 2 and week 4 after treatment and every month thereafter.
- Liver function tests at week 2 after treatment and every month thereafter.
- Renal function tests at week 1 after treatment and every month thereafter.
- Stool samples will be collected from every participant at baseline (before the start of treatment) and at the end of the 16th week of treatment (at the efficacy of treatment assessment visit). Samples will be stored in sterile screw-capped tubes, and kept at -80 ºC, till the time of subsequent experiments.
- Total DNA will be isolated from stool samples using QIAamp DNA Stool Mini Kit following the manufacturer's instructions.
- Illumina Next generation sequencing: The microbiota composition will be determined by amplification of the V3 and V4 hypervariable regions of the 16S rRNA gene using universal primers with Illumina compatible adaptors.
- 16S Metagenomic Sequencing Library will be prepared according to the Illumina Protocol.
- Bioinformatic analysis of 16S rRNA amplicon sequencing data will be performed for classification of reads at taxonomic levels.
- Changes in microbiome profiles of participants will be determined and correlated with the clinical outcome of treatment.
- Statistical analysis: The obtained results from the cases the controls will be statistically analyzed using the appropriate statistical methods.
- Conditions
- Psoriasis (PsO)
- Being tested
- Probiotics and methotrexate, Methotrexate
- Keywords
- Psoriasis, gut microbiome, methotrexate, probiotics
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics and methotrexateDrug
weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics.
MethotrexateDrug
weekly oral methotrexate 15-25 mg/week
| Study group | Role | What they receive |
|---|---|---|
| Probiotics and methotrexate group | Experimental | Patients will receive weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics. Receives: Drug: Probiotics and methotrexate |
| Methotrexate group | Active comparator | Patients will receive weekly oral methotrexate 15-25 mg/week. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone.
The composition of gut microbiota before the start of treatment and after the end of the treatment course will be determined by analysis of a stool sample from each participant by illumina Next generation sequencing and 16S Metagenomics bioinformatics analysis of data to identify microbial taxa in the samples.
The clinical impact induced by treatment of newly diagnosed psoriatic patients with probiotics and methotrexate or methotrxate alone will be determined by the calculation of PASI score before and after treatment.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Aug 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Aliaa Gamaleldin Aboulela, Alexandria University
- Investigators
- Ezzeldin A. Saleh, PhD, Study chair, Medical Research Institute, Alexandria UniversityGamaleldin A. Elsawaf, PhD, Study director, Medical Research Institute, Alexandria UniversityMohamed A. Alqasem, MSc, Principal investigator, Medical Research Institute, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169019
- Sponsor's protocol ID
- E/C. S/N. T24/2025
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mu Q, Kirby J, Reilly CM, Luo XM. Leaky Gut As a Danger Signal for Autoimmune Diseases. Front Immunol. 2017 May 23;8:598. doi: 10.3389/fimmu.2017.00598. eCollection 2017.
PubMed 28588585Strati F, Lattanzi G, Amoroso C, Facciotti F. Microbiota-targeted therapies in inflammation resolution. Semin Immunol. 2022 Jan;59:101599. doi: 10.1016/j.smim.2022.101599. Epub 2022 Mar 15.
PubMed 35304068Celoria V, Rosset F, Pala V, Dapavo P, Ribero S, Quaglino P, Mastorino L. The Skin Microbiome and Its Role in Psoriasis: A Review. Psoriasis (Auckl). 2023 Oct 26;13:71-78. doi: 10.2147/PTT.S328439. eCollection 2023.
PubMed 37908308Navarro-Lopez V, Martinez-Andres A, Ramirez-Bosca A, Ruzafa-Costas B, Nunez-Delegido E, Carrion-Gutierrez MA, Prieto-Merino D, Codoner-Cortes F, Ramon-Vidal D, Genoves-Martinez S, Chenoll-Cuadros E, Perez-Orquin JM, Pico-Monllor JA, Chumillas-Lidon S. Efficacy and Safety of Oral Administration of a Mixture of Probiotic Strains in Patients with Psoriasis: A Randomized Controlled Clinical Trial. Acta Derm Venereol. 2019 Nov 1;99(12):1078-1084. doi: 10.2340/00015555-3305.
PubMed 31453631Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.
PubMed 30793796Brenchley JM, Douek DC. Microbial translocation across the GI tract. Annu Rev Immunol. 2012;30:149-73. doi: 10.1146/annurev-immunol-020711-075001. Epub 2012 Jan 3.
PubMed 22224779Reali E, Caliceti C, Lorenzini A, Rizzo P. The Use of Microbial Modifying Therapies to Prevent Psoriasis Exacerbation and Associated Cardiovascular Comorbidity. Inflammation. 2024 Feb;47(1):13-29. doi: 10.1007/s10753-023-01915-1. Epub 2023 Nov 13.
PubMed 37953417Polak K, Bergler-Czop B, Szczepanek M, Wojciechowska K, Fratczak A, Kiss N. Psoriasis and Gut Microbiome-Current State of Art. Int J Mol Sci. 2021 Apr 26;22(9):4529. doi: 10.3390/ijms22094529.
PubMed 33926088Vicic M, Kastelan M, Brajac I, Sotosek V, Massari LP. Current Concepts of Psoriasis Immunopathogenesis. Int J Mol Sci. 2021 Oct 26;22(21):11574. doi: 10.3390/ijms222111574.
PubMed 34769005
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome Changes and Clinical Impact Induced by Treatment of Newly Diagnosed Psoriasis Patients With Probiotics and Methotrexate: a Pilot Study
- ClinicalTrials.gov ID
- NCT07169019
- Acronym / sponsor ID
- E/C. S/N. T24/2025
- Conditions
- Psoriasis (PsO)
- Keywords
- Psoriasis, gut microbiome, methotrexate, probiotics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (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 goal of this clinical trial is to learn if probiotics work to improve the response of psoriatic patients to methotrexate treatment in adults. It will also learn about the beneficial effect of probiotics on the gut microbiota of psoriatic patients treated with methotrexate. The main questions it aims to answer are:
Do probiotics enhance the reduction of disease burden in psoriatic patients under methotrexate treatment? Do probiotics increase the beneficial gut bacteria and decrease the harmful gut bacteria in psoriatic patients under methotrexate treatment? Researchers will compare probiotics intake along with methotrexate to methotrexate alone to see if probiotics work to enhance the reduction of the severity of psoriasis in patients treated by methotrexate and whether the addition of probiotics will improve their gut health.
Participants will:
Take a daily dose of probiotics with a weekly dose of methotrexate or only a weekly dose of methotrexate for 4 months.
Give daily feedback to the researchers about their probiotic intake and their dietary intake.
Visit the clinic after 1 and 2 weeks of beginning treatment and then once every 4 weeks for checkups and tests.
Detailed description
This study aims to identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard first line treatment with methotrexate alone.
Methods
- Collection of demographic and clinical data:
- Data about the full medical history will be collected for all patients (including name, age, sex, history of the disease, duration of illness, association with other autoimmune diseases like vitiligo, diabetes type 1, etc).
- Data about the results of full clinical examination of all patients will be collected.
- Data about the clinical assessment of the severity of Psoriasis will be collected as indicated by the Psoriasis Activity and Severity Index (PASI) score (which is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance). PASI score will be calculated before treatment and every month during treatment. (Appendix 1)
- Data about base line pretreatment laboratory investigations will be collected: CBC, liver and renal function test.
- Data about follow up lab investigations will be collected:
- CBC at week 2 and week 4 after treatment and every month thereafter.
- Liver function tests at week 2 after treatment and every month thereafter.
- Renal function tests at week 1 after treatment and every month thereafter.
- Stool samples will be collected from every participant at baseline (before the start of treatment) and at the end of the 16th week of treatment (at the efficacy of treatment assessment visit). Samples will be stored in sterile screw-capped tubes, and kept at -80 ºC, till the time of subsequent experiments.
- Total DNA will be isolated from stool samples using QIAamp DNA Stool Mini Kit following the manufacturer's instructions.
- Illumina Next generation sequencing: The microbiota composition will be determined by amplification of the V3 and V4 hypervariable regions of the 16S rRNA gene using universal primers with Illumina compatible adaptors.
- 16S Metagenomic Sequencing Library will be prepared according to the Illumina Protocol.
- Bioinformatic analysis of 16S rRNA amplicon sequencing data will be performed for classification of reads at taxonomic levels.
- Changes in microbiome profiles of participants will be determined and correlated with the clinical outcome of treatment.
- Statistical analysis: The obtained results from the cases the controls will be statistically analyzed using the appropriate statistical methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics and methotrexate group | Experimental | Drug: Probiotics and methotrexatePatients will receive weekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics. |
| Methotrexate group | Active comparator | Drug: MethotrexatePatients will receive weekly oral methotrexate 15-25 mg/week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed patients with chronic plaque psoriasis.
Key exclusion criteria (6 listed)
- • Psoriatic patients who used systemic treatments at least 3 months before the study, with the exception of acetritin use, in the last 3 years.
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 |
|---|---|---|
| Probiotics and methotrexateweekly oral methotrexate 15-25 mg/week, along with an oral daily dose of probiotics. | Drug | Probiotics and methotrexate group |
| Methotrexateweekly oral methotrexate 15-25 mg/week | Drug | Methotrexate group |
Primary outcome
To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone.
Time frame: One year
The composition of gut microbiota before the start of treatment and after the end of the treatment course will be determined by analysis of a stool sample from each participant by illumina Next generation sequencing and 16S Metagenomics bioinformatics analysis of data to identify microbial taxa in the samples. The clinical impact induced by treatment of newly diagnosed psoriatic patients with probiotics and methotrexate or methotrxate alone will be determined by the calculation of PASI score before and after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 28588585Mu Q, Kirby J, Reilly CM, Luo XM. Leaky Gut As a Danger Signal for Autoimmune Diseases. Front Immunol. 2017 May 23;8:598. doi: 10.3389/fimmu.2017.00598. eCollection 2017.
- Results publication: PubMed 35304068Strati F, Lattanzi G, Amoroso C, Facciotti F. Microbiota-targeted therapies in inflammation resolution. Semin Immunol. 2022 Jan;59:101599. doi: 10.1016/j.smim.2022.101599. Epub 2022 Mar 15.
- Results publication: PubMed 37908308Celoria V, Rosset F, Pala V, Dapavo P, Ribero S, Quaglino P, Mastorino L. The Skin Microbiome and Its Role in Psoriasis: A Review. Psoriasis (Auckl). 2023 Oct 26;13:71-78. doi: 10.2147/PTT.S328439. eCollection 2023.
- Results publication: PubMed 31453631Navarro-Lopez V, Martinez-Andres A, Ramirez-Bosca A, Ruzafa-Costas B, Nunez-Delegido E, Carrion-Gutierrez MA, Prieto-Merino D, Codoner-Cortes F, Ramon-Vidal D, Genoves-Martinez S, Chenoll-Cuadros E, Perez-Orquin JM, Pico-Monllor JA, Chumillas-Lidon S. Efficacy and Safety of Oral Administration of a Mixture of Probiotic Strains in Patients with Psoriasis: A Randomized Controlled Clinical Trial. Acta Derm Venereol. 2019 Nov 1;99(12):1078-1084. doi: 10.2340/00015555-3305.
- Results publication: PubMed 30793796Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.
- Results publication: PubMed 22224779Brenchley JM, Douek DC. Microbial translocation across the GI tract. Annu Rev Immunol. 2012;30:149-73. doi: 10.1146/annurev-immunol-020711-075001. Epub 2012 Jan 3.
- Results publication: PubMed 37953417Reali E, Caliceti C, Lorenzini A, Rizzo P. The Use of Microbial Modifying Therapies to Prevent Psoriasis Exacerbation and Associated Cardiovascular Comorbidity. Inflammation. 2024 Feb;47(1):13-29. doi: 10.1007/s10753-023-01915-1. Epub 2023 Nov 13.
- Results publication: PubMed 33926088Polak K, Bergler-Czop B, Szczepanek M, Wojciechowska K, Fratczak A, Kiss N. Psoriasis and Gut Microbiome-Current State of Art. Int J Mol Sci. 2021 Apr 26;22(9):4529. doi: 10.3390/ijms22094529.
- Results publication: PubMed 34769005Vicic M, Kastelan M, Brajac I, Sotosek V, Massari LP. Current Concepts of Psoriasis Immunopathogenesis. Int J Mol Sci. 2021 Oct 26;22(21):11574. doi: 10.3390/ijms222111574.
- Individual participant dataSharing planned: Undecided
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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.
Ezzeldin A. Saleh, PhD study chair
Medical Research Institute, Alexandria University
Gamaleldin A. Elsawaf, PhD study director
Medical Research Institute, Alexandria University
Mohamed A. Alqasem, MSc principal investigator
Medical Research Institute, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Probiotics and methotrexate and Methotrexate in people with Psoriasis (PsO), run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliaa G. Aboulela, PhD (+201002104138, aliaagamaleldin@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone. (time frame: One year). 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 NCT07169019, which also lists 9 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 11 Sep 2025.