Rheumatoid Arthritis (RA)NCT07304505
Probiotics in Adults With Rheumatoid Arthritis
A study testing Align Extra Strength Probiotic Supplement in people with Rheumatoid Arthritis (RA), run by Ancilia Biosciences at 1 site in United States.
Trial summary
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: Have a 6-week daily administration of a probiotic Collect fecal samples every other day during the first 3 weeks of the study and twice weekly over the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Align Extra Strength Probiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent.
- Be 18 years or older.
- Clinical diagnosis of rheumatoid arthritis (RA) for more than 6 months.
- Have been on stable RA treatment for 3 months and are expected to remain on stable RA treatment during the study.
- Willing to consume the study product daily for the duration of the study.
Who cannot join
- 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:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
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- Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
- 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:
- history of mixed connective tissue disease or overlap syndrome (Systemic lupus erythematosus (SLE), Systemic sclerosis (scleroderma), Polymyositis/ dermatomyositis)
- Prior history or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).
- Diagnosed gastrointestinal disease
- Gastrointestinal surgery, excluding cholecystectomy and appendectomy in the last five years.
- Renal failure
- Liver cirrhosis
- 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:
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Exploratory Analysis of Commercial Probiotics in Adults With Rheumatoid Arthritis
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:
- Have a 6-week daily administration of a probiotic
- Collect fecal samples every other day during the first 3 weeks of the study and twice weekly over the last 3 weeks
- Visit the clinic at Baseline, Week 3 and Week 6 for checkup and testing
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Align Extra Strength Probiotic Supplement
- Keywords
- Microbiome, Probiotic
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Align Extra Strength Probiotic SupplementDietary supplement
Bifidobacterium longum subsp. longum 35624™ (50mg): 5 x10^9 (5 billion) live bacteria per capsule
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 6-week daily oral administration of Align Extra Strength Probiotic Supplement, produced by Procter \& Gamble (Bifidobacterium longum subsp. longum 35624™) Receives: Dietary Supplement: Align Extra Strength Probiotic Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start13 Nov 2025
- Primary completion18 Aug 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ancilia Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304505
- Sponsor's protocol ID
- AFCRO-201
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Exploratory Analysis of Commercial Probiotics in Adults With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07304505
- Acronym / sponsor ID
- AFCRO-201
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Microbiome, Probiotic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ancilia BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Have a 6-week daily administration of a probiotic
- Collect fecal samples every other day during the first 3 weeks of the study and twice weekly over the last 3 weeks
- Visit the clinic at Baseline, Week 3 and Week 6 for checkup and testing
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Align Extra Strength Probiotic Supplement6-week daily oral administration of Align Extra Strength Probiotic Supplement, produced by Procter \& Gamble (Bifidobacterium longum subsp. longum 35624™) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be able to give written informed consent.
- Be 18 years or older.
- Clinical diagnosis of rheumatoid arthritis (RA) for more than 6 months.
- Have been on stable RA treatment for 3 months and are expected to remain on stable RA treatment during the study.
- Willing to consume the study product daily for the duration of the study.
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Align Extra Strength Probiotic SupplementBifidobacterium longum subsp. longum 35624™ (50mg): 5 x10^9 (5 billion) live bacteria per capsule | Dietary supplement | Probiotic |
Primary outcome
Probiotic bacterial colonization
Time frame: 6 weeks
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
1 secondary outcome
RA clinical outcomes
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Align Extra Strength Probiotic Supplement in people with Rheumatoid Arthritis (RA), run by Ancilia Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probiotic bacterial colonization (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.