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

NCT06659068 | Active Not Recruiting DMC

• 1 other identifier: 4.3/D.XVIII.6.8/ETIK/208/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Keywords

Seluang fish oil; Rasbora argyrotaenia; Systemic Lupus Erythematosus; SLE; IL-17/IL-10 ratio; CD4+; CD25+; Foxp3+; T-regulator; Disease Activity

Outcome Measures

Primary Outcomes (3)

• CD4+CD25+Foxp3+ regulatory T cells,

  To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo in CD4+CD25+Foxp3+ regulatory T cells concentration change

  From enrollment to the end of the treatment at 12 weeks

• IL-17/IL-10 ratio

  To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo in IL-17/IL-10 ratio changes

  From enrollment to the end of the treatment at 12 weeks

• SLEDAI-2K score

  To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo towards SLEDAI-2K score changes

  From enrollment to the end of the treatment at 12 weeks

Study Arms (2)

Seluang fish oil (Rasbora argyrotaenia) and Synbiotic

EXPERIMENTAL

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

Dietary Supplement: Seluang fish oil (Rasbora argyrotaenia) and synbiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Seluang fish oil (Rasbora argyrotaenia) and synbiotic 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

Seluang fish oil (Rasbora argyrotaenia) and Synbiotic

Placebo DIETARY_SUPPLEMENT

Patients received placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 31198446 BACKGROUND

• 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

• 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

  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: The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 26, 2024
• Study Start: May 16, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

ID (1)