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Efficacy and safety of gut microbiota-based therapies for SLE and LN

Mar 26, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in systemic lupus erythematosus.

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Patients with systemic lupus erythematosus (SLE) experience an imbalance in their intestinal flora. The use of probiotics as an adjunctive therapy may be considered to prevent vascular complications associated with SLE. Current evidence indicates the potential effectiveness of gut microbiota-based therapies for treating SLE and lupus nephritis (LN); however, a systematic summary is lacking. 

Zeng et al.1 recently published an article in BMC Medicine reporting a systematic review and meta-analysis of randomized clinical trials assessing the efficacy and safety of probiotics in the treatment of various autoimmune diseases. Here, we summarize the findings for SLE and LN. 


  • A systematic literature search was performed across multiple databases to identify studies from inception to June 2022. 

  • Outcomes were efficacy indicators (SLE Disease Activity Index [SLEDAI]), inflammatory factor indicators (Complement C3 and immunoglobulin G [IgG]), and adverse events. 

  • Weighted mean differences were utilized to assess continuous variables with uniform measurement units. 

Key findings 

  • A total of four studies were included in the analysis for SLE and LN (Figure 1).1

Figure 1. Study characteristics* 

CFU, colony forming unit; IgG, immunoglobulin G; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.  
*Adapted from Zeng, et al.1


  • Post gut microbiota-based therapy, SLEDAI was significantly lower in the experimental group compared with control group (p<0.00001; Figure 2A).1 

Complement C3 

  • Blood complement C3 levels after gut microbiota-based therapy were significantly higher in the experimental group vs control group (p<0.05).4,5 

IgG level 

  • Compared with control group, the IgG level in the experimental group was significantly lower after probiotic therapy (p<0.00001; Figure 2B).1 

Figure 2. A SLEDAI and B IgG level in patients with SLE and LN after gut microbiota-based therapy*  

CI, confidence interval; IgG, immunoglobulin G; LN, lupus nephritis; SLE, systemic lupus erythematosus; SLEDAI, SLE Disease Activity Index. 
*Adapted from Zeng, et al.1 

Adverse events

  • A study by Huang et al. showed that the incidence of abnormal liver function, diarrhea, infection (upper respiratory tract, lung, and urinary tract), tachycardia, and other adverse events was not significantly different between the experimental group (31.91%) and control group (34.78%).2 

  • Yuan et al. reported that no treatment-associated adverse events were reported.3 

Key learnings

  • Gut mircobiota-based therapy based of Bifidobacteria and Lactobacilli may be effective and well tolerated in patients with SLE and LN. 
  • This meta-analysis offers insights for clinical practicse and serves as a reference for designing future trials.

  1. Zeng L, Yang K, He Q, et al. Efficacy and safety of gut microbiota-based therapies in autoimmune and rheumatic diseases: A systematic review and meta-analysis of 80 randomized controlled trials. BMC Med. 2024;22(1):110. DOI: 10.1186/s12916-024-03303-4 
  2. Huang M, Huang CJ Ou QJ, et al. Study on the effect of probiotics intervention in the treatment of patients with lupus nephritis type IV-V. Chin Gen Pract Med. 2022;25(20):2462-2467. 
  3. Yuan CB, Luo Li, Li YH, et al. Effect of Bifidobacterium Lactobacillus triple viable bacteria adjuvant therapy on the humoral immune function and serum amyloid A level of patients with newly diagnosed systemic lupus erythematosus. China Med Innov. 2021;18(10):70-73. 
  4. Zheng DH. Efficacy of Bifidobacterium Lactobacillus triple viable bacteria combined with prednisone in the treatment of systemic lupus erythematosus. Journal of Guangzhou Medical University. 2022;50(01):61-65. 
  5. Fu BB, Yue CF, Xuan CY, et al. Interventional effect of microecological regulators on newly diagnosed patients with systemic lupus erythematosus. J Clin Intern Med. 2019; 36(08):535-538. 


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