Effects of Probiotics on Rheumatoid Arthritis Patients

NCT00664820 | Completed

• 1 other identifier: R-08-140
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to examine the utility of probiotics as an adjunctive therapy (in addition to patients' pharmacotherapy) for the treatment of Rheumatoid Arthritis. We hypothesize that specifically selected probiotics, Lactobacillus rhamnosus GR-1 and L. reuteri RC-14, can alleviate symptoms of RA and thereby increase the daily activity of these patients.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritics; probiotics; Lactobacillus

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the number of patients that achieve an ACR20 response. So we will compare the number of patients that achieved an ACR20 response in the probiotic group to those that achieved an ACR20 response in the placebo group.

  4 months

Secondary Outcomes (1)

• Immunological parameters (TNFα, IL-12, IL-10 and G-CSF) along with the eight components of the ACR20 response will be the secondary outcomes. Serum creatinine and liver function will be evaluated as parameters of any side effects of the probiotics.

  4 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Will receive two Urex-CAP-5 (probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14) capsules daily for 3 months.

Dietary Supplement: Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14

Interventions

Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 DIETARY_SUPPLEMENT

2 capsules daily for 3 months.

Also known as: Urex-CAP-5 capsule

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between the ages of 18 to 80
• Are clinically diagnosed with RA (according to ACR criteria)
• Have been on stable RA treatment and are expected to stay on stable RA treatment during the time of the study (i.e. ongoing medication and/or other therapy, such as physiotherapy are permitted, except immunotherapy).
• Have at least 4 swollen and tender joints on a 64/66 scale
• Women of childbearing capacity and who agree to an acceptable method of birth control. Acceptable methods of birth control will include: hormone therapy (oral birth control pills, injectable or skin patches), barrier contraceptive with spermacide, an intra uterine device (IUD) or complete abstinence (no sexual intercourse).

You may not qualify if:

• Receiving ongoing immunotherapy for RA
• Has inflammatory bowel disease or leaky gut
• Currently consuming probiotics and refuse to have a two week washout period
• Have known allergies to any component in the study product or placebo
• Plan to have surgery during the time of the study
• Mental illness impairing ability to comply with study
• Women who are pregnant or plan to get pregnant during the study period
• Women who are breastfeeding
• Consumption of probiotic-containing products during study treatment
• Patients participating in another NHP clinical trial
• Patients enrolled in another clinical trial in the past 3 month
• Women who are breastfeeding

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator
• St. Joseph's Health Care London: collaborator

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria Pineda, BA

  Western University, Canada

  STUDY DIRECTOR

• Janet Pope, MD

  St. Joseph's Health Center

  STUDY DIRECTOR

• Gregor Reid, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 23, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

CA (1)