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AzTrials

Systemic Lupus Erythematosus (SLE)NCT06659068

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

A study testing Seluang fish oil (Rasbora argyrotaenia) and synbiotic in people with Systemic Lupus Erythematosus (SLE), run by Universitas Sriwijaya at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
Seluang fish oil (Rasbora argyrotaenia) and synbiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteIndonesia
Study dates
16 May 2024to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Mohammad Hoesin General Hospital

    Palembang, South Sumatera, 30126

Other trials in Indonesia

About this study

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.

Being tested
Seluang fish oil (Rasbora argyrotaenia) and synbiotic, Placebo
Keywords
Seluang fish oil, Rasbora argyrotaenia, Systemic Lupus Erythematosus, SLE, IL-17/IL-10 ratio, CD4+, CD25+, Foxp3+, T-regulator, Disease Activity
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seluang fish oil (Rasbora argyrotaenia) and synbioticDietary 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

  • PlaceboDietary supplement

    Patients received placebo capsules

Study groups in NCT06659068
Study groupRoleWhat they receive
Seluang fish oil (Rasbora argyrotaenia) and SynbioticExperimentalSeluang 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
Receives: Dietary Supplement: Seluang fish oil (Rasbora argyrotaenia) and synbiotic
PlaceboPlacebo comparatorPlacebo The patients were given placebo capsules of seluang fish oil (Rasbora argyrotaenia) and synbiotics once a day
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From enrollment to the end of the treatment at 12 weeks

  2. 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

    Measured: From enrollment to the end of the treatment at 12 weeks

  3. SLEDAI-2K score

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

    Measured: From enrollment to the end of the treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start16 May 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659068
Sponsor's protocol ID
4.3/D.XVIII.6.8/ETIK/208/2023
Status last verified
Oct 2024
First submitted
30 Sep 2024
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31198446

  • 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.

    PubMed 36359816

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Seluang fish oil (Rasbora argyrotaenia) and synbiotic in people with Systemic Lupus Erythematosus (SLE), run by Universitas Sriwijaya at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4+CD25+Foxp3+ regulatory T cells, (time frame: From enrollment to the end of the treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659068, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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