Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02804581|
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Gum Arabic (GA) rich dietary fiber it is a water-soluble dietary fiber derived from the dried gummy exudates of the stems and branches of Acacia senegal, GA found to have strong immuno modulator in vitro where it increased IL10 production showing strong anti-inflammatory effects (19).
The aim of this study is to determine the role of gum Arabic in immunomodulation among patients with rheumatoid arthritis.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Dietary Supplement: Gum Arabic||Phase 2|
Butyrate is short chain fatty acids representing the most important end product of colonic bacterial aerobic fermentation of Gum Arabic , it has a potent anti-inflammatory effect and can down regulates TNF a expression by modulating NF-kB-DNA binding activity , in addition butyrate is known to act as histone deacetylase inhibitor in the cells.Recently, in vitro and in vivo data indicates that HDAC inhibitors may have anti-inflammatory effect due to their effects on cell death acting through acetylation of non-histone proteins. The possible anti-rheumatic mechanisms of HDAC inhibitors, including growth arrest in rheumatoid arthritis synovial fibroblasts (RASFs), suppression of pro-inflammatory cytokines, suppressing angiogenesis as well as the protective effects on bone and cartilage against their destruction.
The investigators expect regular intake of GA will raise serum butyrate level. The endogenous butyrate decreases the TNF level. The latter will decrease the number of relapsing episodes, arresting the destruction of joints and improve both survival and life quality of rheumatoid arthritis patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||October 2016|
Experimental: Gum Arabic
Oral intake of 30 gram of Gum Arabic daily for 12 weeks
Dietary Supplement: Gum Arabic
Oral intake of GA in powder from30 grams per day
- The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF [ Time Frame: 12 weeks ]
- clinical improvement [ Time Frame: 12 weeks ]
- Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804581
|Contact: Ebtihal K Obied, MBBS||. 00249912279229||E.Kamal.Ali@hotmail.com|
|Contact: Lamis AM Kaddam, MBBS,PhDemail@example.com|
|Military Hospital Rheumatology||Recruiting|
|Khartoum, Umdorman, Sudan, 1121|
|Contact: Alnour Elagib, MBBS,MRCP,MD 00249912306262 firstname.lastname@example.org|
|Principal Investigator: Ebtihal Obied, MBBS|
|Sub-Investigator: Alnour Elagib, MBBS,MRCP,MD|
|Study Chair:||Alnour Alagib, MBBS,MD,MRCP||Military hospital|
|Study Director:||Amal M Saeed, MBBS,PhD||University of Khartoum|