NCT02804581

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

June 15, 2016

Last Update Submit

June 19, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (2)

  • clinical improvement

    12 weeks

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

    12 weeks

Study Arms (1)

Gum Arabic

EXPERIMENTAL

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

Dietary Supplement: Gum Arabic

Interventions

Gum ArabicDIETARY_SUPPLEMENT

Oral intake of GA in powder from30 grams per day

Gum Arabic

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • hepatic, cardiovascular, pulmonary, malignant, hematologic, neurologic, infectious, or inflammatory diseases unrelated to Rheumatoid arthritis.
  • Hospital admission within 4 weeks of start of the study.
  • Uncontrolled hypertension 4- Asthma or severe atopic disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital Rheumatology

Khartoum, Umdorman, 1121, Sudan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20511709BACKGROUND

  • 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.

    PMID: 17325655BACKGROUND

  • 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.

    PMID: 30112005DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Alnour Alagib, MBBS,MD,MRCP

    Military hospital

    STUDY CHAIR

  • Amal M Saeed, MBBS,PhD

    University of Khartoum

    STUDY DIRECTOR

Central Study Contacts

Ebtihal K Obied, MBBS

CONTACT

. 00249912279229E.Kamal.Ali@hotmail.com

Lamis AM Kaddam, MBBS,PhD

CONTACT

00249912979736lamiskaddam@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

SU(1)