Efectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémica
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Small intestinal Bacterial Overgrowth (Presence or absence)
研究概览
简要总结
Introduction. Autonomic dysfunction, smooth muscle fibrosis and vascular damage lead to small intestinal bacterial overgrowth (SIBO) in Systemic Sclerosis (SSc). SIBO is characterized by diarrhea, abdominal pain, bloating, malabsorption and malnutrition.
Aim. To evaluate the efficacy and safety of Saccharomyces boulardii in combination with metronidazole for 2 months for reducing gastrointestinal symptoms (NIH-PROMIS) and preventing bacterial overgrowth (hydrogen breath test) versus the standard treatment in patients with systemic sclerosis.
Method. Controlled clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. NIH PROMIS®questionarie will be apply to evaluate gastrointestinal symptoms and classify in not symptomatic, least, mildy, moderately and most symptomatic. Glucose HBT will be apply after 14 hours fast, oral hygiene and 30 days free of antibiotics to evaluate SIBO. Patients with negative HBT and symptoms associated to glucose ingestion will repeat test with lactulose. Patients will be aleatorized into 1. Saccharomyces boulardii, 2. Metronidazole and 3. Metronidazole plus Saccharomyces boulardii.
All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.
详细描述
The study will be carried out with prior authorization from the Local Research and Ethics Committee. Patients entitled to our healthcare services and complying with screening criteria will be included.
Patients with scleroderma included in our database will be invited to participate in the study through a telephone call. Patients complying with the screening criteria and accepting to participate in the study will be given a date for an interview.
On the day of the interview, they will be given the informed consent form. Once it has been signed, they will be asked to complete the NIH PROMIS questionnaire for gastrointestinal symptoms. In order to validate the questionnaire, it will be translated from English into Spanish, then back-translated from Spanish into English and submitted to a panel of gastroenterology experts. Once patients have completed the questionnaire, a Cronbach's alpha test will be carried out. Another visit will be scheduled two weeks later to perform the hydrogen breath test and patients will be given instructions to help them complete the test.
On the second visit (two weeks later), the following parameters will be recorded: weight (measured with a Seca scale without shoes and wearing a hospital gown), height, abdominal girth at the level of the navel (using a measuring tape), and patients will take the hydrogen breath test (Gastrolyzer instrument). Patients with a positive result will be randomly assigned to one of three groups: group 1 (Saccharomyces boulardii), group 2 (metronidazole) or group 3 (metronidazole + Saccharomyces boulardii).
Group 1. Saccharomyces boulardii 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Social security beneficiaries affiliated to the "LA RAZA" UMAE HECMN
- •Adults over 18 years old
- •Male or female subjects
- •Diagnosed with scleroderma (2013 ACR-EULAR)
- •Score above the 25th percentile in NIH-PROMIS questionnaire
- •Positive result (> 10 ppm) in the hydrogen breath test
- •Normal leukocyte and lymphocyte profiles
- •Patients who accept to participate in the study by signing the informed consent form
排除标准
- •Gastrointestinal diseases already diagnosed and not associated to systemic sclerosis
- •Comorbidities associated to visceral diseases (diabetes, amyloidosis or other infiltrative diseases)
- •Currently under biological treatment (or history of biological treatment in the last year) with cyclophosphamide and > 10 mg prednisone or equivalent
- •Allergy or contra-indications to metronidazole or to Saccharomyces boulardii,
- •Central venous catheter carriers
研究组 & 干预措施
Saccaromyces boulardii oral tablet
Saccharomyces boulardii Oral Tablet 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.
干预措施: Saccharomyces Boulardii Oral Tablet (Drug)
Metronidazole plus S. boulardii
Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months.
干预措施: Saccharomyces Boulardii Oral Tablet (Drug)
Metronidazole plus S. boulardii
Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months.
干预措施: Metronidazole (Drug)
Metronidazole
Metronidazole 500 mg b.i.d during 1 week, plus Saccharomyces boulardii 200 mg b.i.d. during 1 week, follow for only Saccharomyces 200 mg b.i.d. for one another week, 2-week rest period and then this regimen is repeated for two consecutive months.
干预措施: Metronidazole (Drug)
结局指标
主要结局
Small intestinal Bacterial Overgrowth (Presence or absence)
时间窗: baseline, second month
Small intestinal Bacterial Overgrowth will be measured by a breath test using a hydrogen monitor. Hydrogen is part of the bacteria metabolism and can be detected in breath. it can be quantified in parts per million. We wil consider presence of Small intestinal Bacterial Overgrowth if a measure \> 10 part per million is obtained in our patients. We will compare the presence or abscense of Small intestinal bacterial overgrowth after the intervention.
次要结局
- Intensity of gastrointestinal symptoms(baseline, second month)
研究者
Maria del Pilar Cruz Dominguez
Chief of Researh Division
Coordinación de Investigación en Salud, Mexico