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The goal of this clinical study is to collect data on the effect of probiotic administration on clinical outcomes in rheumatoid arthritis patients.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 6-week daily oral administration of Align Extra Strength Probiotic Supplement, produced by Procter & Gamble (Bifidobacterium longum subsp. longum 35624â„¢) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Align Extra Strength Probiotic Supplement | Dietary Supplement | Bifidobacterium longum subsp. longum 35624â„¢ (50mg): 5 x10^9 (5 billion) live bacteria per capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probiotic bacterial colonization | Change from baseline (Day 0) to Day 39 (including intermediate time points) in the relative abundance and/or detection frequency of the administered probiotic strain in stool | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RA clinical outcomes | Change from baseline (Day 0) to Day 21, and Day 39 on Rheumatoid Arthritis clinical outcomes as assessed by Clinical Disease Activity Index (CDAI) Total Score based on: Tender joint count, Swollen joint count, Patient Global disease Activity, Evaluator Global disease Activity. CDAI score is the sum of these components, ranging from 0 to 76, where higher scores are worse outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Occurrence of any adverse events (AEs/SAEs) and/or changes in vital signs (Blood Pressure, Heart Rate, and Temperature) during probiotic administration | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
Has a history of drug and/or alcohol abuse.
Has food allergies or other issues with foods that would preclude intake of the Study Products including milk and soy allergies.
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
Current or recent (in the past 8-weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
a. Antibiotics
Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:
a. Probiotics
Current or recent (in the past 2-weeks) use of yoghurts containing probiotics.
Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacey Boetto, DNP, FNP-C | Contact | 312-535-9440 | sboetto@atlantiatrials.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 6 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |