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

NCT07048470 | Completed DMC

• 1 other identifier: DP.04.03/D.XVIII.6.8/ETIK/163
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

systemic lupus erythematosus; SLE; synbiotics; disease activity; MEX-SLEDAI; IL-10; TGF-β

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Synbiotic

EXPERIMENTAL

The patients were given a capsule containing synbiotic once a day

Dietary Supplement: Synbiotic

Placebo

PLACEBO COMPARATOR

The patients were given placebo capsules once a day

Dietary Supplement: Placebo

Interventions

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

Synbiotic

Placebo DIETARY_SUPPLEMENT

Patients received placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. SLE with pulmonary tuberculosis. 6. Currently undergoing antibiotic therapy. 7. SLE with malignancy.
• Drop-Out Criteria
• Patients discontinue synbiotic intake for more than 2 weeks.
• Death.
• Occurrence of serious adverse drug reactions requiring discontinuation of the study drug.
• 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.
• Patients require hospitalization due to symptom exacerbation during the intervention period.
• Loss to follow-up.

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 36359816 BACKGROUND

• 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.

  PMID: 33642142 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 2, 2025
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

ID (1)