A clinical trial with the aim of investigating the multi-therapeutic effect of Lactobacillus roteri, Lactobacillus rhamnosus and Bifidobacterium infante on IL-6 and TNF-a cytokines in patients with systemic lupus erythematosus

The effect of probiotics Lactobacillus reuteri, Lactobacillus rhamnosus and Bifidobacterium infanti on serum levels of IL-6 and TNF-α in patients with systemic lupus erythematosus

Patients are divided into two equal groups using the randomization method (23 people in each group). In the treatment group, in addition to common treatments for systemic lupus erythematosus, three probiotics Lactobacillus roteri, Lactobacillus rhamnosus, and Bifidobacterium are consumed daily in a capsule, and in the other group, in addition to common treatments, placebo is consumed instead of three probiotics. The duration of the intervention is 2 months.

Before and after the intervention, 5 cc of blood will be collected from the patients' brachial veins to assess immunological responses; the serum is stored in the freezer at the Immunology Research Center of the Bo Ali Research Institute in Mashhad. In the immunology laboratory of North Khorasan Faculty of Medical Sciences, IL-6 and TNF-cytokines will be determined via the ELISA technique.

Inclusion criteria: Patients with mild to moderate systemic lupus erythematosus based on the SLEDAI score, aged 20 to 55 years. Exclusion criteria: Patients with no underlying disease, such as kidney transplant, or who receive immunosuppressive drugs unrelated to systemic lupus erythematosus.

In the intervention group, in addition to common treatments for systemic lupus erythematosus, three probiotics Lactobacillus roteri, Lactobacillus rhamnosus, and Bifidobacterium are consumed daily in a capsule

Evaluation of interleukin 6 (IL-6) and Tumor necrosis Factor alpha (TNF-α) and Systemic Lupus Erythematosus Disease Activity (SLEDAI)

Randomization: In this study, Block Randomization method with 13 blocks size 4 will be used. We will use Excel software and function (rand) to prepare random sequences. The steps of doing randomization using Excel: 1. Make a column group with A,A,B,B,C,C 2. In another column: =rand(). Assign random numbers to each letter. While doing this, use "paste values" to stop recalculating the randomization. =rand() 3. Sorting. Sort the random numbers from the lowest to the highest with selecting expand selection. 4. Sequence. Copy group column and paste it in sequence. 5. Repeat above steps 11 times And a repeat with block size 2. 6. Finish. Save the record. Concealment: A specific numerical code will be assigned to each of the randomly created sequences. Randomization will be done by the study epidemiologist and information will be only given to a study staff at the time of initiation of the intervention.

This study is a double-blind randomized clinical trial, in other words, in this study, the researcher and the patient do not know the type of drug used (probiotic and placebo). In this study, drugs are sent in two separate boxes with codes A and B. The nature of the boxes will be reported only after taking the drug and collecting clinical and laboratory data.

All data will be shared, including the amount of medication, duration of medication use, and all outcomes.

All data will be published after the study is done

Data will be made available to all researchers upon request

Analyzed data and clinical results of treatment effect in patients are accessible

Clinical trial registrar

Request from the trial registrar by email