Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- 1. Proportion of patients with improvement in distention/bloating scale ≥ 0.14 at the end of 4 weeks. A change of 0.14 is the minimally important difference for this scale(9)
研究概览
简要总结
Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely debilitating and even life-threatening. Some problems associated with GIT disorders may include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing, constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract), diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines), and the inability to control your bowel movements.
Probiotics are the "good bacteria" normally found in your digestive tract. Our group is looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of these symptoms in scleroderma patients that have GIT disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient ≥18 years.
- •Patients with SSc with moderate-to-severe distention/bloating on GIT
- •scale (scale score >1.00).
- •Stable immunosuppressive therapy(ies) for ≥ 1 month.
- •Stable PPI and/or other anti-reflux medications for ≥ 1 month.
- •Stable calcium channel blocker for ≥ 1 month.
- •Stable NSAID for ≥ 1 month.
- •Stable dose of pro-motility agent for ≥ 1 month.
- •Exclusion criteria:
- •Recent diagnosis for small intestinal bacterial overgrowth (SIBO) during last 1 month.
- •Treatment with antibiotics within last 2 weeks.
- •Currently receiving chemotherapy (pulse cyclophosphamide). It is acceptable to be on methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine.
- •Severe diarrhea (Diarrhea scale score of ≥ 1.01; may suggest untreated SIBO).
- •History of inherited or acquired immunodeficiency
排除标准
- 未提供
研究组 & 干预措施
placebo
Subjects will be randomized into either the probiotic or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
干预措施: Lactobacillus (Drug)
Probiotic
Subjects will be randomized into either the probiotic or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
干预措施: Lactobacillus (Drug)
结局指标
主要结局
1. Proportion of patients with improvement in distention/bloating scale ≥ 0.14 at the end of 4 weeks. A change of 0.14 is the minimally important difference for this scale(9)
时间窗: 12 months
次要结局
未报告次要终点
研究者
Dinesh Khanna, MD, MS
Associate Professor
University of Michigan