Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients (ESSENTIAL)

Universitas Sriwijaya

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Dietary Supplement: Synbiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07048470

DP.04.03/D.XVIII.6.8/ETIK/163

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. All patients diagnosed with mild to moderate Systemic Lupus Erythematosus (SLE).
2. Patients aged over 18 years.
3. Willing to participate in the study by signing an informed consent form.
4. Have not consumed yogurt or supplements containing probiotics, prebiotics, or synbiotics within the last 2 weeks.

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.

2. SLE with pulmonary tuberculosis. 6. Currently undergoing antibiotic therapy. 7. SLE with malignancy.

Drop-Out Criteria

1. Patients discontinue synbiotic intake for more than 2 weeks.
2. Death.
3. Occurrence of serious adverse drug reactions requiring discontinuation of the study drug.
4. 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.
5. Patients require hospitalization due to symptom exacerbation during the intervention period.
6. Loss to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Synbiotic

Experimental group

Description:

The patients were given a capsule containing synbiotic once a day

Treatment:

Dietary Supplement: Synbiotic

Placebo

Placebo Comparator group

Description:

The patients were given placebo capsules once a day

Treatment:

Dietary Supplement: Placebo