Ankylosing SpondylitisNCT07834788
Lacticaseibacillus Rhamnosus GG Supplementation in Active Ankylosing Spondylitis
A study testing Lacticaseibacillus rhamnosus GG in people with Ankylosing Spondylitis, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to learn whether Lacticaseibacillus rhamnosus GG supplementation improves disease activity, physical function, and inflammatory markers in adults with active ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Lacticaseibacillus rhamnosus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Mar 2019
- Phase
- Interventional
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 25-65 years Physician-established diagnosis of ankylosing spondylitis
- Active-phase disease at screening, defined by all of the following:
- BASDAI > 3 BASFI > 3 C-reactive protein (CRP) > 5 mg/L Erythrocyte sedimentation rate (ESR) > 15 mm/h
Who cannot join
- Use of any prebiotic, probiotic, or synbiotic product within the preceding 3 months Pregnancy or lactation Presence of any other chronic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University Balcalı Hospital
Adana, Balcalı, 01330
About this study
Official title: Lacticaseibacillus Rhamnosus GG Supplementation Does Not Reduce Disease Activity, CRP or ESR Beyond Placebo in Active Ankylosing Spondylitis: A Randomized, Double-Blind Trial
The goal of this clinical trial was to learn whether Lacticaseibacillus rhamnosus GG supplementation improves disease activity, physical function, and inflammatory markers in adults with active ankylosing spondylitis. The main questions it aimed to answer were:
Does Lacticaseibacillus rhamnosus GG supplementation reduce disease activity and improve physical function, as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI)? Does Lacticaseibacillus rhamnosus GG supplementation reduce C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)? Researchers compared Lacticaseibacillus rhamnosus GG supplementation with a placebo (an identical capsule containing no active ingredient) to determine whether probiotic supplementation provides additional benefits in adults with active ankylosing spondylitis.
Read more
Participants:
Took one capsule containing Lacticaseibacillus rhamnosus GG (6 × 10⁹ colony-forming units) or an identical placebo capsule once daily immediately after a meal for 8 weeks.
Continued their existing pharmacological treatment without changes during the study.
Attended study visits at baseline and every 15 days during the 8-week study period.
Had disease activity, physical function, CRP, and ESR assessed at baseline and at the end of week 8.
Had dietary intake, anthropometric measurements, and body composition assessed during the study.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Lacticaseibacillus rhamnosus GG, Placebo
- Keywords
- Ankylosing Spondylitis, Lacticaseibacillus rhamnosus GG, Probiotics, Gut Microbiota, C-Reactive Protein (CRP)
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus rhamnosus GGDietary supplement
Participants received one capsule containing 6 × 10^9 colony-forming units (CFU) of Lacticaseibacillus rhamnosus GG once daily, immediately after a meal, for 8 weeks. The probiotic was obtained from a commercial pharmacy. Participants continued their existing pharmacological treatment without changes throughout the study.
PlaceboOther
A visually identical capsule containing no active ingredient, taken once daily immediately after a meal for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lacticaseibacillus rhamnosus GG Group | Experimental | Participants received one capsule containing 6 × 10^9 colony-forming units (CFU) of Lacticaseibacillus rhamnosus GG once daily, immediately after a meal, for 8 weeks. Participants continued their existing pharmacological treatment without changes during the study. Receives: Dietary Supplement: Lacticaseibacillus rhamnosus GG |
| Placebo Group | Placebo comparator | Participants received one visually identical placebo capsule containing no active ingredient once daily, immediately after a meal, for 8 weeks. Participants continued their existing pharmacological treatment without changes during the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive Protein (CRP
Serum C-reactive protein (CRP) concentration was measured in mg/L using the routine clinical laboratory assay.
Measured: Baseline and Week 8
Erythrocyte Sedimentation Rate (ESR)
Erythrocyte sedimentation rate (ESR) was measured in mm/h using the routine clinical laboratory assay.
Measured: Baseline and Week 8
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Disease activity was assessed using the BASDAI. The total score ranges from 0 to 10, with higher scores indicating greater disease activity
Measured: Baseline and Week 8
Bath Ankylosing Spondylitis Functional Index (BASFI)
Physical function was assessed using the BASFI. The total score ranges from 0 to 10, with higher scores indicating greater functional impairment.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834788
- Sponsor's protocol ID
- 12-2018/54
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No