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Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 2
Locations
Sudan
Study Type
Interventional
Intervention
Gum Arabic
Sponsored by
Lamis Kaddam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Military Hospital RheumatologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gum Arabic

Arm Description

Oral intake of 30 gram of Gum Arabic daily for 12 weeks

Outcomes

Primary Outcome Measures

The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF

Secondary Outcome Measures

clinical improvement
Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level

Full Information

First Posted
June 15, 2016
Last Updated
June 19, 2016
Sponsor
Lamis Kaddam
Collaborators
University of Khartoum, Military hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02804581
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lamis Kaddam
Collaborators
University of Khartoum, Military hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gum Arabic
Arm Type
Experimental
Arm Description
Oral intake of 30 gram of Gum Arabic daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Gum Arabic
Intervention Description
Oral intake of GA in powder from30 grams per day
Primary Outcome Measure Information:
Title
The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
clinical improvement
Time Frame
12 weeks
Title
Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Rheumatoid Arthritis Clinically stable as evidenced by medical history, complete physical examination All medications and dosages are stable for 6 weeks before study entry, 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebtihal K Obied, MBBS
Phone
. 00249912279229
Email
E.Kamal.Ali@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lamis AM Kaddam, MBBS,PhD
Phone
00249912979736
Email
lamiskaddam@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alnour Alagib, MBBS,MD,MRCP
Organizational Affiliation
Military hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amal M Saeed, MBBS,PhD
Organizational Affiliation
University of Khartoum
Official's Role
Study Director
Facility Information:
Facility Name
Military Hospital Rheumatology
City
Khartoum
State/Province
Umdorman
ZIP/Postal Code
1121
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alnour Elagib, MBBS,MRCP,MD
Phone
00249912306262
Email
elagib62@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ebtihal Obied, MBBS
First Name & Middle Initial & Last Name & Degree
Alnour Elagib, MBBS,MRCP,MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20511709
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.
Results Reference
background
PubMed Identifier
17325655
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.
Results Reference
background
PubMed Identifier
30112005
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.
Results Reference
derived

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Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients

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