Lacticaseibacillus Rhamnosus GG Supplementation Does Not Reduce Disease Activity, CRP or ESR Beyond Placebo in Active Ankylosing Spondylitis: A Randomized, Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- C-Reactive Protein (CRP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Use of any prebiotic, probiotic, or synbiotic product within the preceding 3 months Pregnancy or lactation Presence of any other chronic disease
研究组 & 干预措施
Lacticaseibacillus rhamnosus GG Group
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.
干预措施: Lacticaseibacillus rhamnosus GG (Dietary Supplement)
Placebo Group
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.
干预措施: Placebo (Other)
结局指标
主要结局
C-Reactive Protein (CRP
时间窗: Baseline and Week 8
Serum C-reactive protein (CRP) concentration was measured in mg/L using the routine clinical laboratory assay.
Erythrocyte Sedimentation Rate (ESR)
时间窗: Baseline and Week 8
Erythrocyte sedimentation rate (ESR) was measured in mm/h using the routine clinical laboratory assay.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
时间窗: 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
Bath Ankylosing Spondylitis Functional Index (BASFI)
时间窗: 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.
次要结局
未报告次要终点