Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2016 |
| First Submitted: | 06/14/2016 |
| Estimated Enrollment Submitted: | 06/14/2016 |
| First Posted: | 06/16/2016 |
| Last Update Submitted: | 06/18/2016 |
| Last Update Posted: | 06/20/2016 |
| Actual Study Start Date: | 05/31/2016 |
| Estimated Primary Completion Date: | 09/30/2016 |
| Estimated Study Completion Date: | 09/30/2016 |
Condition or disease
Intervention/treatment
Dietary Supplement: Gum Arabic
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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; |
Outcome
Primary Outcome Measures
1. The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF [12 weeks]
Secondary Outcome Measures
1. clinical improvement [12 weeks]
2. Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level [12 weeks]
