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Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02804581
Enrollment
45
Registered
2016-06-17
Start date
2016-06-30
Completion date
2016-10-31
Last updated
2016-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DIETARY_SUPPLEMENTGum Arabic

Oral intake of GA in powder from30 grams per day

Sponsors

University of Khartoum
CollaboratorOTHER
Military hospital
CollaboratorUNKNOWN
Lamis Kaddam
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frame
The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF12 weeks

Secondary

MeasureTime frame
clinical improvement12 weeks
Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level12 weeks

Countries

Sudan

Contacts

Primary ContactEbtihal K Obied, MBBS
E.Kamal.Ali@hotmail.com. 00249912279229
Backup ContactLamis AM Kaddam, MBBS,PhD
lamiskaddam@hotmail.com00249912979736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026