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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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 and TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Triple (Participant, Care Provider, Investigator)

Study Groups

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Synbiotic

The patients were given a capsule containing synbiotic once a day

Group Type EXPERIMENTAL

Synbiotic

Intervention Type 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

Placebo

The patients were given placebo capsules once a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Patients received placebo capsules

Interventions

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Synbiotic

The patients received synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Patients received placebo capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

5\. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yuniza

Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR