Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
The purpose of the weight-loss study is to characterize the effect of LGG supplementation on the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota pattern and the degree of weight-loss post-surgery.
The investigators hypothesize that LGG administration will result in a "leaner" pattern of gut microbiota that will lead to higher weight loss at 3 months post-surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Able to give informed consent and report on side effects
- •Tolerating an oral/enteral diet
- •Stable comorbid conditions
排除标准
- •Pregnancy (urine test done on all patients routinely pre-op)/ unwilling to comply with contraceptive requirement after gastric bypass surgery
- •Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
- •Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
- •Presence of an absolute neutrophil count less than 500 per cubic mm (must have had a Complete Blood Count within the last 6 months) or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm.
- •History of adverse reaction to product containing lactobacillus
- •Active colitis (*see definition below)
- •Known or suspected allergies to probiotics, lactobacillus, milk protein, or microcrystalline cellulose
- •Structural heart disease, history of endocarditis or valve replacement, implanted cardiac device, congestive heart failure
- •Positive baseline stool culture for LGG
- •Recent or planned chemotherapy or radiation therapy
- •Solid organ transplant within the prior year
- •Stem cell transplant within the prior year
- •On active immunosuppressive medication [anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than ½ mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids]
- •Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin)
- •Participating in another clinical trial
- •Uncontrolled psychiatric illness
研究组 & 干预措施
Placebo
Placebo to be taken orally for 44 days.
干预措施: Placebo (Dietary Supplement)
LGG Administration
Lactobacillus Rhamnosus GG (LGG) will be taken orally for 44 days. The daily dose is 2*10^10 organisms. The LGG is contained in capsules (1*10^10 organisms per capsule), and two capsules will be taken per day.
干预措施: Lactobacillus Rhamnosus GG (Dietary Supplement)
结局指标
主要结局
Weight Loss
时间窗: 4 months
次要结局
- Percentage of Bacteria Phyla(4 months)