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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.
This research is a double blind randomized controlled trial study. The study subjects were 36 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received synbiotic supplementation once daily for 12 weeks and the group that received placebo. Serum IL-10 and TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Experimental | The patients were given a capsule containing synbiotic once a day |
|
| Placebo | Placebo Comparator | The patients were given placebo capsules once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement | The patients received synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| IL-10 | To determine the effectiveness of adding synbiotics compared to placebo on IL-10 concentration change in Systemic Lupus Erythematosus Patients | From enrollment to the end of the treatment at 12 weeks |
| TGF-B | To determine the effectiveness of adding synbiotics compared to placebo on TGF-B concentration change in Systemic Lupus Erythematosus Patients | From enrollment to the end of the treatment at 12 weeks |
| MEX-SLEDAI score | To determine the effectiveness of adding synbiotics compared to placebo towards MEX-SLEDAI score changes | From enrollment to the end of the treatment at 12 weeks |
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Inclusion Criteria
Exclusion Criteria
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.
Drop-Out Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Hoesin General Hospital | Palembang | South Sumatera | 30126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36359816 | Background | Widhani A, Djauzi S, Suyatna FD, Dewi BE. Changes in Gut Microbiota and Systemic Inflammation after Synbiotic Supplementation in Patients with Systemic Lupus Erythematosus: A Randomized, Double-Blind, Placebo-Controlled Trial. Cells. 2022 Oct 29;11(21):3419. doi: 10.3390/cells11213419. | |
| 33642142 | Background |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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This research is a double blind randomized controlled trial study. The study subjects were 36 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received synbiotic supplementation once daily for 12 weeks and the group that received placebo. Serum IL-10, TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
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Triple (Participant, Care Provider, Investigator)
| Placebo | Dietary Supplement | Patients received placebo capsules |
|
| Askari G, Ghavami A, Shahdadian F, Moravejolahkami AR. Effect of synbiotics and probiotics supplementation on autoimmune diseases: A systematic review and meta-analysis of clinical trials. Clin Nutr. 2021 May;40(5):3221-3234. doi: 10.1016/j.clnu.2021.02.015. Epub 2021 Feb 17. |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |