- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804581
Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients
Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ebtihal K Obied, MBBS
- Phone Number: . 00249912279229
- Email: E.Kamal.Ali@hotmail.com
Study Contact Backup
- Name: Lamis AM Kaddam, MBBS,PhD
- Phone Number: 00249912979736
- Email: lamiskaddam@hotmail.com
Study Locations
-
-
Umdorman
-
Khartoum, Umdorman, Sudan, 1121
- Recruiting
- Military Hospital Rheumatology
-
Contact:
- Alnour Elagib, MBBS,MRCP,MD
- Phone Number: 00249912306262
- Email: elagib62@hotmail.com
-
Principal Investigator:
- Ebtihal Obied, MBBS
-
Sub-Investigator:
- Alnour Elagib, MBBS,MRCP,MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of Rheumatoid Arthritis
- Clinically stable as evidenced by medical history, complete physical examination
- All medications and dosages are stable for 6 weeks before study entry,
- Non Pregnant ladies.
Exclusion Criteria:
1- hepatic, cardiovascular, pulmonary, malignant, hematologic, neurologic, infectious, or inflammatory diseases unrelated to Rheumatoid arthritis.
2-Hospital admission within 4 weeks of start of the study.
3- Uncontrolled hypertension 4- Asthma or severe atopic disease;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gum Arabic
Oral intake of 30 gram of Gum Arabic daily for 12 weeks
|
Oral intake of GA in powder from30 grams per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical improvement
Time Frame: 12 weeks
|
12 weeks
|
Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alnour Alagib, MBBS,MD,MRCP, Military Hospital
- Study Director: Amal M Saeed, MBBS,PhD, University of Khartoum
Publications and helpful links
General Publications
- Xuan NT, Shumilina E, Nasir O, Bobbala D, Gotz F, Lang F. Stimulation of mouse dendritic cells by Gum Arabic. Cell Physiol Biochem. 2010;25(6):641-8. doi: 10.1159/000315083. Epub 2010 May 18.
- Adcock IM. HDAC inhibitors as anti-inflammatory agents. Br J Pharmacol. 2007 Apr;150(7):829-31. doi: 10.1038/sj.bjp.0707166. Epub 2007 Feb 26.
- Kamal E, Kaddam LA, Dahawi M, Osman M, Salih MA, Alagib A, Saeed A. Gum Arabic Fibers Decreased Inflammatory Markers and Disease Severity Score among Rheumatoid Arthritis Patients, Phase II Trial. Int J Rheumatol. 2018 Jul 5;2018:4197537. doi: 10.1155/2018/4197537. eCollection 2018.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Khartoum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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