Rheumatoid ArthritisPhase 2NCT02804581
Gum Arabic as Immunomodulator In Rheumatoid Arthritis Patients
A Phase 2 study testing Gum Arabic in people with Rheumatoid Arthritis, run by Lamis Kaddam at 1 site in Sudan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Gum Arabic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSudan
- Study dates
- Jun 2016to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Sudan1 site, 1 recruiting
- Recruiting
Military Hospital Rheumatology
Khartoum, Umdorman, 1121
Alnour Elagib, MBBS,MRCP,MD, 00249912306262, elagib62@hotmail.com
Ebtihal Obied, MBBS
About this study
Official title: Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Gum Arabic
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum ArabicDietary supplement
Oral intake of GA in powder from30 grams per day
| Study group | Role | What they receive |
|---|---|---|
| Gum Arabic | Experimental | Oral intake of 30 gram of Gum Arabic daily for 12 weeks Receives: Dietary Supplement: Gum Arabic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF
Measured: 12 weeks
Secondary outcomes (2)
clinical improvement
Measured: 12 weeks
Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lamis Kaddam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Khartoum, Military hospital
- Responsible party
- Sponsor-investigator, Lamis Kaddam, Al-Neelain University
- Investigators
- Alnour Alagib, MBBS,MD,MRCP, Study chair, Military hospitalAmal M Saeed, MBBS,PhD, Study director, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804581
- Sponsor's protocol ID
- University of Khartoum
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20511709Adcock 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.
PubMed 17325655Kamal 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.
PubMed 30112005
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Gum Arabic as Immunomodulator In Sudanese Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT02804581
- Acronym / sponsor ID
- University of Khartoum
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Lamis KaddamUniversity, hospital or other
- Collaborators
- University of Khartoum, Military hospital
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gum Arabic | Experimental | Dietary Supplement: Gum ArabicOral intake of 30 gram of Gum Arabic daily for 12 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum ArabicOral intake of GA in powder from30 grams per day | Dietary supplement | Gum Arabic |
Primary outcome
The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF
Time frame: 12 weeks
2 secondary outcomes
clinical improvement
Time frame: 12 weeks
Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H2O2) level
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Background: PubMed 20511709Xuan 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.
- Background: PubMed 17325655Adcock 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.
- Derived from this study: PubMed 30112005Kamal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alnour Alagib, MBBS,MD,MRCP study chair
Military hospital
Amal M Saeed, MBBS,PhD study director
University of Khartoum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gum Arabic in people with Rheumatoid Arthritis, run by Lamis Kaddam at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebtihal K Obied, MBBS (. 00249912279229, E.Kamal.Ali@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of C reactive protein (CRP)and Tumer necrosis factor alpha TNF (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804581, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.