Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804581
• Other study ID #: University of Khartoum
• Status: Recruiting
• Phase: Phase 2
• First received: June 15, 2016
• Last updated: June 19, 2016
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• Source: Al-Neelain University
• Contact: Ebtihal K Obied, MBBS
• Phone: . 00249912279229
• Email: E.Kamal.Ali[@]hotmail.com
• Is FDA regulated: No
• Health authority: Sudan: National Medicines and Poisons Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of Rheumatoid Arthritis

2. Clinically stable as evidenced by medical history, complete physical examination

3. All medications and dosages are stable for 6 weeks before study entry,

4. 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Gum Arabic
Oral intake of GA in powder from30 grams per day

Locations

Country	Name	City	State
Sudan	Military Hospital Rheumatology	Khartoum	Umdorman

Sponsors (3)

Lead Sponsor	Collaborator
Lamis Kaddam	Military hospital, University of Khartoum

Country where clinical trial is conducted

Sudan, 

References & Publications (2)

Adcock IM. HDAC inhibitors as anti-inflammatory agents. Br J Pharmacol. 2007 Apr;150(7):829-31. Epub 2007 Feb 26. — View Citation

Xuan NT, Shumilina E, Nasir O, Bobbala D, Götz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF		12 weeks	No
Secondary	clinical improvement		12 weeks	No
Secondary	Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level		12 weeks	No