Systemic Lupus ErythematosusPhase 2NCT05433857
Probiotics in Systemic Lupus Erythematosus
A Phase 2 study testing Lacteol forte capsules in people with Systemic Lupus Erythematosus, run by Ain Shams University at 1 site in Egypt.
Trial summary
Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Lacteol forte capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2022to 28 Feb 2024
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, male or female.
- Patients are willing to sign a written informed consent.
- Patients fulfilling American college of rheumatology classification criteria for SLE.
- Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.
Who cannot join
- Patients ˂ 18 years or ˃65 years of age.
- Patients with a history of drug allergies to probiotics administration.
- Pregnant or breastfeeding females.
- Current probiotics use.
- Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
- patients suffering from active severe neuropsychiatric manifestations of SLE.
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- Patients with other auto-immune diseases.
- Patients suffering from any type of cancer.
- patients participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus
Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.
Read the detailed description
- Patients will be recruited and evaluated for eligibility.
- Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.
- Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks.
- Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.
- Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study.
- Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.
- Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Lacteol forte capsules
- Keywords
- Probiotics, Lactobacillus, Systemic lupus erythematosus, SLEDAI-2K
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacteol forte capsulesDrug
Also called lactobacillus delbruekii and lactobacillus fermentum
probiotic Lacteol Forte® capsules (5 billion heat-killed Lactobacillus LB, corresponding to lactobacillus delbruekii and lactobacillus fermentum) Two capsules are To be taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 20 patients will receive the standard therapy for 12 weeks |
| Interventional group | Experimental | 20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks Receives: Drug: Lacteol forte capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4
Measured: At baseline and at 12 weeks
Secondary outcomes (5)
Improvement of immunologic parameters
Anti-dsDNA levels
Measured: At baseline and at 12 weeks
Improvement of serum complement
Complements 3 and 4
Measured: At baseline and at 12 weeks
patients' quality of life
Assessment of patients' quality of life using the validated Arabic Lupus Patient-reported outcome survey version 1.8 (LupusPROv1.8)
Measured: At baseline and at 12 weeks
Pain assessment
Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire
Measured: At baseline and at 12 weeks
Incidence of potential adverse effects
Monitoring for side and/or adverse effects
Measured: Weekly up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start10 Jun 2022
- Primary completion30 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, Prospective, randomized, controlled, open-label study.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sayed Fouad, Ain Shams University
- Investigators
- Rana Sayed, PhD, Study director, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433857
- Sponsor's protocol ID
- RHDIRB2020110301 REC 80
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05433857
- Acronym / sponsor ID
- RHDIRB2020110301 REC 80
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Probiotics, Lactobacillus, Systemic lupus erythematosus, SLEDAI-2K
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 27 Jun 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.
Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.
Detailed description
- Patients will be recruited and evaluated for eligibility.
- Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.
- Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks.
- Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.
- Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study.
- Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.
- Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, Prospective, randomized, controlled, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –20 patients will receive the standard therapy for 12 weeks |
| Interventional group | Experimental | Drug: Lacteol forte capsules20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years, male or female.
- Patients are willing to sign a written informed consent.
- Patients fulfilling American college of rheumatology classification criteria for SLE.
- Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.
Key exclusion criteria (9 listed)
- Patients ˂ 18 years or ˃65 years of age.
- Patients with a history of drug allergies to probiotics administration.
- Pregnant or breastfeeding females.
- Current probiotics use.
- Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end 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 |
|---|---|---|
| Lacteol forte capsulesAlso: lactobacillus delbruekii and lactobacillus fermentumprobiotic Lacteol Forte® capsules (5 billion heat-killed Lactobacillus LB, corresponding to lactobacillus delbruekii and lactobacillus fermentum) Two capsules are To be taken once daily | Drug | Interventional group |
Primary outcome
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time frame: At baseline and at 12 weeks
Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4
5 secondary outcomes
Improvement of immunologic parameters
Time frame: At baseline and at 12 weeks
Improvement of serum complement
Time frame: At baseline and at 12 weeks
patients' quality of life
Time frame: At baseline and at 12 weeks
Pain assessment
Time frame: At baseline and at 12 weeks
Incidence of potential adverse effects
Time frame: Weekly up to 12 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 19 Nov 2025.
- 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.
Rana Sayed, PhD study director
Faculty of Pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacteol forte capsules in people with Systemic Lupus Erythematosus, run by Ain Shams 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 4 inclusion and 9 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 19 Nov 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?
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?
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?
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (time frame: At baseline and at 12 weeks). 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 19 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.