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

October 23, 2024 updated by: Yuniza, Universitas Sriwijaya
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30126
        • Mohammad Hoesin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Dietary supplement: 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
Placebo Comparator: Placebo

Placebo

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CD4+CD25+Foxp3+ regulatory T cells,
Time Frame: From enrollment to the end of the treatment at 12 weeks
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
Time Frame: From enrollment to the end of the treatment at 12 weeks
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
Time Frame: From enrollment to the end of the treatment at 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitas Sriwijaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4.3/D.XVIII.6.8/ETIK/208/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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