NCT07048470Completed
Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients
Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients; A Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Jul 2025
Brief summary (registry, in English)
Dysregulation of normal flora leads to dysbiosis, which has recently been investigated as an important internal environmental factor and has been proven to be associated with both active and remission phases of SLE, and can be used to predict disease activity. Administration of synbiotics is expected to restore mucosal barrier function and create an anti-inflammatory environment in the gut, by suppressing pro-inflammatory factors and increasing anti-inflammatory factors (IL-10 and TGF-β), leading to improved disease activity in SLE patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 20 Jun 2025
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Universitas Sriwijaya
- Diseases
- Lupus (SLE)
- NCT number
- NCT07048470
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 1 Dec 2023 to the primary completion date, 1 Mar 2024
- 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
- Occurrence of serious adverse drug reactions requiring discontinuation of the study drug.
- Patients consume yogurt or supplements containing probiotics/synbiotics more than once per week outside of the study intervention, or undergo changes in steroid-sparing agents during the study period.
Other illness
- 1\. Severe SLE. 2, Pregnant or breastfeeding. 3. History of allergy to probiotics or prebiotics. 4. Patients with other immune-related disorders, whether autoimmune or immunocompromised conditions such as HIV or rheumatoid arthritis.
- 5\. SLE with pulmonary tuberculosis. 6. Currently undergoing antibiotic therapy. 7. SLE with malignancy.
Other
- Drop-Out Criteria
- Patients discontinue synbiotic intake for more than 2 weeks.
- Death.
- Patients require hospitalization due to symptom exacerbation during the intervention period.
- Loss to follow-up.
Who the study is looking for
- All patients diagnosed with mild to moderate Systemic Lupus Erythematosus (SLE).
- Patients aged over 18 years.
- Willing to participate in the study by signing an informed consent form.
- Have not consumed yogurt or supplements containing probiotics, prebiotics, or synbiotics within the last 2 weeks.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mohammad Hoesin General Hospital Coordinator of this site? Confirm its status | Palembang | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.