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Completed

NCT Number: NCT07834788

Lacticaseibacillus Rhamnosus GG Supplementation in Active Ankylosing Spondylitis

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.

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çukurova University Balcalı Hospital

Adana, Balcalı, 01330, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Use of any prebiotic, probiotic, or synbiotic product within the preceding 3 months Pregnancy or lactation Presence of any other chronic disease

Treatment and study plan

Lacticaseibacillus rhamnosus GG

Dietary 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.

Placebo

Other

A visually identical capsule containing no active ingredient, taken once daily immediately after a meal for 8 weeks.

Primary outcomes

  1. C-Reactive Protein (CRP

    Time frame: Baseline and Week 8

    Serum C-reactive protein (CRP) concentration was measured in mg/L using the routine clinical laboratory assay.

  2. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline and Week 8

    Erythrocyte sedimentation rate (ESR) was measured in mm/h using the routine clinical laboratory assay.

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Baseline and Week 8

    Disease activity was assessed using the BASDAI. The total score ranges from 0 to 10, with higher scores indicating greater disease activity

  4. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Baseline and Week 8

    Physical function was assessed using the BASFI. The total score ranges from 0 to 10, with higher scores indicating greater functional impairment.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Lacticaseibacillus Rhamnosus GG Supplementation Does Not Reduce Disease Activity, CRP or ESR Beyond Placebo in Active Ankylosing Spondylitis: A Randomized, Double-Blind Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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