Clinical trial NCT02804581: Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients
Official title: Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Al-Neelain University
Sponsor class: OTHER
Collaborators: name: University of Khartoum
name: Military hospital
First posted: 2016-06-17
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF
timeFrame: 12 weeks
Secondary outcomes:
measure: clinical improvement
timeFrame: 12 weeks
measure: Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Military Hospital Rheumatology
state: Umdorman
Study officials:
affiliation: Military hospital
name: Alnour Alagib, MBBS,MD,MRCP
role: STUDY_CHAIR
affiliation: University of Khartoum
name: Amal M Saeed, MBBS,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.