Effects of Probiotics on Rheumatoid Arthritis Patients

NCT ID: NCT00664820

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-07-31

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.

Detailed Description

Patients between 18 - 80 years old who have Rheumatoid arthritis with at least 4 swollen and tender joints will be randomized to receive by mouth two capsules containing placebo or probiotic, Lactobacillus rhamnosus GR-1 and L. reuteri RC-14, daily. The subjects will continue to take the placebo or probiotic, in addition to their RA medications (i.e. ongoing medication and/or other therapy, such as physiotherapy are permitted, except immunotherapy) for three months.

At day 0 (visit #1) (when recruited and just prior to starting to take capsules), at day 45 (visit #2), and at day 90 (visit #3), blood samples of approximately 40 ml of blood (8 teaspoons) will be collected by clinical technicians working in the Lab Test Centre at St. Joseph's Health Center. The blood samples will be used to evaluate Erythrocyte Sedimentation Rate (ESR) and C-reactive protein level. In addition, immunological markers like TNFα, IL-12, IL-10 and G-CSF will also be measured. Serum creatinine and liver function will be evaluated as parameters of any side effects of the probiotics.

Probiotics/placebo will be dispensed from the pharmacy and provided to the subjects by the study investigator at the first visit (for the first 45 days) and second visit (for the final 45 days).

At day 0, 45 and 90 (visits 1, 2 and 3) a physical exam will be completed, where the physician will count the number of swollen and tender joints and complete the Physician Global Assessment of Disease activity. In addition, at these times, the patients will be asked to complete the following self-administered questionnaires:

• Health Assessment Questionnaire (HAQ);
• Patient's Global Assessment of Disease Activity
• Patient Assessment of Pain and Assessment of Duration of Morning stiffness.

Patients will also be asked about feeling fatigued or sleepy, as these are standard questions that come with the above-mentioned questionnaires. These are simple questionnaires that will take approximately 15 minutes to complete. In visit 2 and 3 the physician will confirm if the participant is taking the study capsule/placebo correctly, review any new medications the patient has taken since the last visit and will ask about adverse events that may have occurred.

At day 90, subjects will stop taking capsules.

A follow-up phone call will take place 30 days after the completion of the study medication (day 120). If a patient is withdrawn or withdraws from the study prematurely, he/she will be asked to receive a follow-up telephone call 30 days from the date they last took the study product. During the phone call, which should not take more than 10 minutes, the participant will be asked about any medications taken in the past month and about any possible side effects (unwanted effects or health problems) that they may have experienced.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

2 capsules daily for 3 months.

Interventions

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

2 capsules daily for 3 months.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Urex-CAP-5 capsule

Eligibility Criteria

Inclusion Criteria

1. Are between the ages of 18 to 80

2. Are clinically diagnosed with RA (according to ACR criteria)

3. 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).

4. Have at least 4 swollen and tender joints on a 64/66 scale

5. 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).

Exclusion Criteria

1. Receiving ongoing immunotherapy for RA

2. Has inflammatory bowel disease or leaky gut

3. Currently consuming probiotics and refuse to have a two week washout period

4. Have known allergies to any component in the study product or placebo

5. Plan to have surgery during the time of the study

6. Mental illness impairing ability to comply with study

7. Women who are pregnant or plan to get pregnant during the study period

8. Women who are breastfeeding

9. Consumption of probiotic-containing products during study treatment

10. Patients participating in another NHP clinical trial

11. Patients enrolled in another clinical trial in the past 3 month

12. Women who are breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

St. Joseph's Health Care London

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Gregor Reid

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Pineda, BA

Role: STUDY_DIRECTOR

Western University, Canada

Janet Pope, MD

Role: STUDY_DIRECTOR

St. Joseph's Health Center

Gregor Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

Other Identifiers

R-08-140

Identifier Type: -

Identifier Source: org_study_id