Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00664820
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).
6. Patients who did not meet any of the exclusion criteria stated below.
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00664820
Study Brief:
Protocol Section:
NCT00664820