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Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients

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ClinicalTrials.gov Identifier: NCT02804581
Recruitment Status : Unknown
Verified June 2016 by Lamis Kaddam, Al-Neelain University.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborators:
University of Khartoum
Military hospital
Information provided by (Responsible Party):
Lamis Kaddam, Al-Neelain University

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Gum Arabic Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients
Study Start Date : June 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. clinical improvement [ Time Frame: 12 weeks ]
  2. Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804581


Contacts
Contact: Ebtihal K Obied, MBBS . 00249912279229 E.Kamal.Ali@hotmail.com
Contact: Lamis AM Kaddam, MBBS,PhD 00249912979736 lamiskaddam@hotmail.com

Locations
Sudan
Military Hospital Rheumatology Recruiting
Khartoum, Umdorman, Sudan, 1121
Contact: Alnour Elagib, MBBS,MRCP,MD    00249912306262    elagib62@hotmail.com   
Principal Investigator: Ebtihal Obied, MBBS         
Sub-Investigator: Alnour Elagib, MBBS,MRCP,MD         
Sponsors and Collaborators
Lamis Kaddam
University of Khartoum
Military hospital
Investigators
Study Chair: Alnour Alagib, MBBS,MD,MRCP Military hospital
Study Director: Amal M Saeed, MBBS,PhD University of Khartoum

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lamis Kaddam, Dr, Al-Neelain University
ClinicalTrials.gov Identifier: NCT02804581     History of Changes
Other Study ID Numbers: University of Khartoum
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Adjuvants, Immunologic
Physiological Effects of Drugs