NCT04367428Unknown3 期
Effects of Pre- and Postoperative Probiotics Administration on Postoperative Weight Loss in Patients Undergoing Sleeve Gastrectomy
Hospital General Universitario Elche0 个研究点目标入组 60 人开始时间: 2020年5月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 主要终点
- Weight loss
研究概览
简要总结
Patients will be randomized into 2 groups:
- G1: Patients undergoing sleeve gastrectomy as bariatric procedure and receiving pre- and postoperative probiotics
- G2: Patients undergoing sleeve gastrectomy as bariatric procedure and not receiving pre- or postoperative probiotics
Weight loss will be assessed 1 year after surgery
详细描述
Patients will be randomized into 2 groups:
- G1: Patients undergoing sleeve gastrectomy as bariatric procedure and receiving pre- and postoperative probiotics
- G2: Patients undergoing sleeve gastrectomy as bariatric procedure and not receiving pre- or postoperative probiotics
Preoperative probiotics scheme include:
- saccharomyces boulardii ntc 5375 + enterococcus faecium UBEF-41 + lactobacillus acidophilus LA 14 during 15 days (between 6th and 4th weeks before surgery)
- Bifidobacterium lactis BL 04 + Bifidobacterium breve BB 03 + Bifidobacterium bifidum BB 06 + Bifidobacterium longum BL 05 during 15 days (between 4th and 2nd weeks before surgery)
- lactobacillus rhamnosus LR 32 + lactobacillus rhamnosus HN001 + lactobacillus acidophillus LA 14 during 15 days (between 2nd week and the day before surgery)
Postoperative probiotics scheme include:
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
- •BMI >35 associated to diabetes mellitus, hypertension, dyslipidemia or sleep apnea/hypopnea síndrome
- •Patients undergoing laparoscopic sleeve gastrectomy as primary bariatric procedure
排除标准
- •Revisional surgery
- •Patients with gastroesophageal reflux disease
- •Patients planned for a sleeve gastrectomy as first step of a second malabsorptive procedure
- •Patients with immune deficiencies or with chronic intake of immune supressor drugs
- •patients refusing to participate in the study
结局指标
主要结局
Weight loss
时间窗: 1 year after surgery
Weight loss will be assessed as excess body mass index (BMI) loss, calculated by the formula: Excess BMI loss= (preoperative BMI-postoperative BMI)/ (preoperative BMI-25)
次要结局
- Remission of diabetes mellitus(1 year after surgery)
- Remission of dyslipidemia(1 year after surgery)
研究者
Jaime Ruiz-Tovar, MD, PhD
Head of Bariatric Surgery Unit
Hospital General Universitario Elche
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