Pilot Study of the Effectiveness of Probiotics and Lactitol for the Intestinal Decolonization of People Carriers of Klebsiella Pneumoniae Producers of Carbapenemase OXA-48-type: DesProbiOXA Study
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people.
研究概览
简要总结
The combination of Lactitol and Probiotics (Lactobacillus acidophilus and Lactobacillus Biphidus) administered orally is an effective strategy of intestinal decolonization of Enterobacter produced OXA-48-type carbapenemase.
The purpose of this study is to determine the effectiveness of Lactitol and Probiotics for the intestinal decolonization of people who carried Klebsiella pneumoniae produced OXA-48-type Carbapenemase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women over 18 years old
- •Have signed the informed consent to participate.
- •Have evidence of intestinal colonization by KP-OXA-48 during the period of screening.
- •Start of intestinal colonization by KP-OXA-48, > 6 months of starting treatment.
- •Absence of exclusion criteria
排除标准
- •Be hospitalized for an acute process at the time of inclusion.
- •Take antibiotics (oral , intramuscular or intravenous ) at the time of inclusion.
- •Having diarrhea in the two weeks prior to the inclusion.
- •Baseline electrolyte abnormalities requiring supplementation : Hypokalemia (K <3 mEq / L), hypomagnesemia (Mg <1.8 mEq / L ), hypocalcemia (Ca < 8mg/dL )
- •Suffering from digestive diseases : Crohn's disease, ulcerative colitis , celiac disease, irritable bowel syndrome , intestinal resection, colostomies.
- •Neutropenia ( neutrophil count < 1.00 x 10 3 / uL ) or other situations of severe immunosuppression , including continued use of systemic steroids (at least 1mg/kg/day of prednisone or equivalent for more than 1 month) and other forms of pharmacological immunosuppression deemed by the investigator.
- •Diabetes mellitus poorly controlled ( HgA1c > 8 mmol / mol ).
- •Taking antisecretory inhibitors, proton pump or anti -H
- •Advanced chronic renal failure (GFR < 30 ml / min)
- •Being a carrier of endovascular prosthetic devices, including long-term central catheters.
- •Having significant valvulopathy on the opinion of the investigator.
- •Surgical intervention of gastrointestinal tract in the last three months.
- •Treatment with systemic corticosteroids or immunosuppressive.
- •Allergy or intolerance to lactose or lactitol or Infloran .
研究组 & 干预措施
Lactitol and Lactobacillus
Lactitol monohydrated 10g (Emportal®), 1 sachet dissolved in water, three times a day for 21 days.
Lactobacillus acidophilus, 1 x 109 UFC and Lactobacillus Biphidus 1 x 109 UFC, (Infloran Berna), 2 tablets by mouth, three times a day for 21 days.
干预措施: Lactitol (Drug)
Lactitol and Lactobacillus
Lactitol monohydrated 10g (Emportal®), 1 sachet dissolved in water, three times a day for 21 days.
Lactobacillus acidophilus, 1 x 109 UFC and Lactobacillus Biphidus 1 x 109 UFC, (Infloran Berna), 2 tablets by mouth, three times a day for 21 days.
干预措施: Lactobacillus (Drug)
结局指标
主要结局
Evaluate the effectiveness of the combination of lactitol and probiotics, administered orally to achieve intestinal decolonization of KP-OXA-48 in people.
时间窗: Six weeks
次要结局
- Evaluate the effectiveness of lactitol and probiotics administered orally for intestinal decolonization of KPOXA -48 in people.(Three weeks and six weeks)
- Evaluate the safety and tolerability of the combination of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) measured by the increase of diarrhea, flatulence, abdominal pain, loss of appetite and weight loss(Three weeks)
- Analyze the effect of the combination of lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) administered orally on intestinal microbiota of carriers of KP- OXA -48(Three weeks)
- Evaluate the time from the start of treatment with lactitol and probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum ) to intestinal decolonization in those patients who achieved sustained response.(Six weeks)