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NCT Number: NCT03140657

The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis Patients

Ankylosing Spondylitis (AS) is a chronic rheumatic disease that principally affects the intervertebral and sacroiliac joints. Two major features of AS are inflammation and bone reformation. Th17 cells as a new subpopulation of CD4+ T cells, are characterized by the production of pro-inflammatory cytokines. Th17 cells have been implicated in autoimmune diseases, pathogenesis and diagnosis of several inflammatory diseases, such as AS. Regulatory T cells (Treg) with suppressive effects on inflammation and autoimmunity have been reported to implicate in pathology of AS. The Treg /Th17 functional balance is essential for the prevention of autoimmune and inflammatory diseases by preventing deleterious impairment to the host and mounting effective immune responses. A group of circulating miRNA in plasma is found to be the change they can be involved in inflammation or inhibit it. miRNAs have been shown to play a pivotal role in the pathogenesis of various diseases including autoimmune or auto-inflammatory diseases.The function and molecular pathways of several key deregulated miRNAs, are elucidated in AS patients. Curcumin is an active component of turmeric which is a perennial plant. Curcumin is able to exert anti-atherogenic, anti-cancer and anti-inflammatory effects. The curcumin induces down-regulation of various inflammatory cytokines including TNF-α and IL-1. The solubility of curcumin in nanomicelles spherical water increases to more than 100 thousand times, which significantly enhances the absorption of curcumin. The aim of the present study was to understand the nano-curcumin effects on frequency of Treg and Th17 cells, expression levels of their associated transcription factors and cytokines, secretion levels of their associated cytokines and also related miRNAs expression levels in peripheral blood of patients with AS and their correlation with the disease progression.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

23 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Connective Tissue Diseases Research Center

Tabriz, 0413, Iran

About this study

A16-weeks randomized placebo-controlled study was conducted on a total of 24 patients with age range of 22 to 50, who were clinically diagnosed with ankylosing spondylitis on the basis of clinical manifestations. The AS patients were divided into 2 subgroup with a block randomization, 12 out of 24 received a daily dose of 80 mg oral nano-curcumin and 12 patients received placebo as control group in a period of 4 months. Peripheral blood samples (8 ml) were obtained from the patients in both control and treatment groups before and after nano-curcumin treatment for 4 months. PBMCs were isolated from samples using Ficoll separation technique. Subsequently, cells were cultured in the presence of PMA. Treg cells associated immunological parameters such as mRNA expression levels of mir-146a, mir-27 and mir-17, TGF-β, IL-10, IL-6 and FoxP3 and alsoTh17 related immunological parameters such as mRNA expression of mir-141, mir-155 and mir-200, IL-17, IL-23 and RORγt were measured by real-time PCR, also Treg and Th17 frequency and their related cytokines secretion levels were evaluated respectively by flowcytometry and ELISA technique in both groups, pre and post-treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willingness to cooperate
  • Aged 22 to 50 years
  • The diagnosis of ankylosing spondylitis by rheumatologist
  • Patients with a BASDAI > 4 as having active disease.
  • Disease duration 5-8 years

Exclusion criteria

  • Nutritional supplements and antioxidant alpha-lipoic acid a month before the study.
  • Pregnancy and lactation
  • History of diabetes and other chronic diseases
  • History of other autoimmune diseases
  • Occurrence of relapses during the study period
  • Acceptance rate of less than 70% of supplements
  • Unwillingness to continue to cooperate

Treatment and study plan

Nanocurcumin

Drug

Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 months

Placebo

Drug

Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 months

Primary outcomes

  1. Assessments of Ankylosing Spondylitis Signs and Symptoms (BASDI)

    Time frame: 4 months after treatment

    Number of Subjects With a Reduction in Signs and Symptoms

Secondary outcomes

  1. mir-141, mir-155 and mir-200 expression

    Time frame: 4 months after treatment

    qPCR method (mir-141, mir-155 and mir-200 induces differentiation of Th17 cells and increase inflammation)

  2. Serum IL-17 levels

    Time frame: 4 months after treatment

    Elisa method (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).

  3. RORγt expression

    Time frame: 4 months after treatment

    qPCR method (RoRγt, a transcription factor, induce Th17 cell differentiation and increase inflammation).

  4. IL-17 expression

    Time frame: 4 months after treatment

    qPCR method (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).

  5. Th17 cells frequency

    Time frame: 4 months after treatment

    Flowcytometry (Th17 cells produce inflammatory cytokine, IL17, and increase inflammation).

  6. mir-27, mir-17 and mir-146a expression

    Time frame: 4 months after treatment

    PCR method (mir-27, mir-17 and mir-146a induces differentiation of Treg cells)

  7. Serum TGF-β, IL-10, IL-6 levels

    Time frame: 4 months after treatment

    Elisa method (Treg cells produce anti-inflammatory cytokine, and decrease inflammation).

  8. FoxP3 expression

    Time frame: 4 months after treatment

    qPCR method (FoxP3, a transcription factor, induce Treg cell differentiation and decrease inflammation).

  9. TGF-β, IL-10, IL-6 expression

    Time frame: 4 months after treatment

    qPCR method (Treg cells produce anti-inflammatory cytokine, and decrease inflammation).

  10. Treg cells frequency

    Time frame: 4 months after treatment

    Flowcytometry (Treg cells produce anti-inflammatory cytokine, and decrease inflammation).

Sponsors and collaborators

Lead sponsor

Tabriz University of Medical Sciences

Other

Registry information

Official study title

The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 4, 2017
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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