NCT05433857CompletedPhase 2
Probiotics in Systemic Lupus Erythematosus
Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 17 Jun 2022
- Start date
- 10 Jun 2022
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Ain Shams University
- Diseases
- Lupus (SLE)
- NCT number
- NCT05433857
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 10 Jun 2022 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
Other illness
- Patients with a history of drug allergies to probiotics administration.
- Patients with other auto-immune diseases.
- Patients suffering from any type of cancer.
Age
- Patients ˂ 18 years or ˃65 years of age.
Other
- Pregnant or breastfeeding females.
- Current probiotics use.
- patients suffering from active severe neuropsychiatric manifestations of SLE.
- patients participating in other clinical trials.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain Shams University Hospitals Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.