Efficacy of Seluang Fish Oil (Rasbora Argyrotaenia) and Synbiotics Supplementation on CD4+CD25+ Foxp3+ T-regulator Cells, IL17/IL-10 Ratio, and Disease Activity in Systemic Lupus Erythematosus Patients

NCT ID: NCT06659068

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2025-01-31

Brief Summary

The study aimed to evaluate the efficacy of seluang fish oil (Rasbora argyrotaenia) and synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation compared to placebo towards Systemic Lupus Erythematosus disease activity Index (SLEDAI)-2K score, IL-17/IL-10 ratio and CD4+ CD25+ Foxp3+T-regulator levels in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited 18-55 years old SLE patients diagnosed based on SLICC criteria, with mild to moderate disease activity, were clinically stable for ≥ 4 months (on prednison ≤ 20 mg/day or equivalent) and willingly ceased vitamin D and probiotic consumption during the trial study. Participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo. Evaluations were conducted on week 4, 8 and 12 for clinical symptoms, side effects and adherence. IL-17/IL-10 ratio and CD4+ CD25+ Foxp3+T-regulator levels were evaluated at the beginning and at the end of the 12 week trial for analysis.

Conditions

Systemic Lupus Erythematosus (SLE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Seluang fish oil (Rasbora argyrotaenia) and Synbiotic

Seluang fish oil (Rasbora argyrotaenia) and Synbiotic

The patients were given a capsule containing seluang fish oil (Rasbora argyrotaenia) once a day and also synbiotic once a day

Group Type: EXPERIMENTAL

Seluang fish oil (Rasbora argyrotaenia) and synbiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo

The patients were given placebo capsules of seluang fish oil (Rasbora argyrotaenia) and synbiotics once a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Patients received placebo capsules

Interventions

Seluang fish oil (Rasbora argyrotaenia) and synbiotic

The patients received seluang fish oil (Rasbora argyrotaenia) and 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

Inclusion Criteria

• Patients who meet the SLICC criteria
• Patients with mild to moderate SLE (mild if SLEDAI-2K score < 6 and moderate if SLEDAI-2K score: 6-12)
• Aged 18-55 years
• Willing to stop consuming vitamin D or multivitamin supplements containing vitamin D for at least 3 weeks before participating in the study
• Willing to stop consuming probiotics that were previously taken for at least 1 week before participating in the study
• If using prednisone, the dose must be stable (corticosteroid equivalent ≤ 20 mg/day) for at least 4 weeks before the study
• Willing to sign informed consent

Exclusion Criteria

• Patients with severe SLE
• Patients with SLE with hypercalcemia (> 2.60 mmol/l)
• Patients with SLE with liver dysfunction: serum Aspartate Transferase (AST) - and Alanine Transferase (ALT) levels > 2 times the normal value or total serum bilirubin > 1.5 times the normal value
• Patients undergoing hemodialysis or patients with serum creatinine > 2.5 mg/dL
• Pregnant patients
• Patients with SLE with immunocompromised conditions such as HIV
• Patients with SLE with chronic infections such as pulmonary tuberculosis
• Patients currently undergoing antibiotic therapy

Drop out criteria:

• Patients who have been off medication for more than 3 weeks
• Patients who have passed away
• Patients who consume yogurt or supplements containing probiotics/synbiotics more than once consecutively in 1 week
• Patients who experience a change in immunosuppressive agents during the study
• Patients who are hospitalized due to a worsening condition during the intervention period
• Loss to follow-up

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Sriwijaya

OTHER

Sponsor Role: lead

Responsible Party

Yuniza

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohammad Hoesin General Hospital

Palembang, South Sumatera, Indonesia

Countries

Indonesia

References

Partan RU, Hidayat R, Saputra N, Rahmayani F, Prapto H, Yudha TW. Seluang Fish (Rasbora Spp.) Oil Decreases Inflammatory Cytokines Via Increasing Vitamin D Level in Systemic Lupus Erythematosus. Open Access Maced J Med Sci. 2019 May 5;7(9):1418-1421. doi: 10.3889/oamjms.2019.308. eCollection 2019 May 15.

Reference Type: BACKGROUND

PMID: 31198446 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36359816 (View on PubMed)

Partan RU, Mart Salim E, Hidayat R. The potential role of seluang fish oil (Rasbora Spp) in improving calcium, zinc and vitamin d3 deficiencies. International Journal of Oceans and Oceanography. 2017: 11; 2. 285-29

Reference Type: BACKGROUND

Other Identifiers

4.3/D.XVIII.6.8/ETIK/208/2023

Identifier Type: -

Identifier Source: org_study_id