The Impact of Hafnia Alvei on Weight Loss and Glycaemic Control After Bariatric Surgery - A Randomized, Triple-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y gastric bypass will receive probiotics or placebo, twice a day, for 90 days, one month after surgery. Outcomes will be measured at baseline, and 3, 6, 9 and 12 months after the surgery.
详细描述
Gut microbiota dysbiosis is associated with the pathophysiology of obesity. Bariatric surgery is an effective treatment for obesity that induces changes in the gut microbiota. However, recent studies indicate that the gut microbiota is not fully restored after bariatric surgery which may limit the potential of the surgery to achieve metabolic control and maintain weight loss. Thus, modulating the gut microbiota with probiotics after bariatric surgery could be an effective strategy to improve the success of the surgery.
This study aims to investigate the effects of Hafnia alvei HA4597 TM supplementation on weight loss and glycemic control after bariatric surgery. Patients undergoing Roux-en-Y gastric bypass will receive probiotics or placebo, twice a day, for 90 days, one month after surgery. Outcomes will be measured at baseline, and 3, 6, 9 and 12 months after the 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
- Triple (Participant, Care Provider, Investigator)
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
- •Men and women between 18 and 65 years
- •BMI ≥35 kg/m2 and at least one severe obesity-related complications, or BMI ≥40 kg/m2
- •Undergoing Roux-en-Y gastric bypass
- •Willing to take a probiotic/placebo supplement twice a day for 60 days
- •Willing and able to provide written informed
排除标准
- •Intake of antibiotics and/or probiotics in the previous 12 weeks
- •Weight change >5% in the previous 12 weeks
- •Diagnosis of gastrointestinal disease or other significant illness
- •Pregnancy or breastfeeding
研究组 & 干预措施
Probiotic group
Two capsules of Hafnia alvei HA4597™ probiotic/day (5 x 107 CFU/day) for 90 days
干预措施: Hafnia alvei HA4597™ (Dietary Supplement)
Placebo group
Two identical capsules of placebo/day for 90 days
干预措施: Placebo (Other)
结局指标
主要结局
HbA1c
时间窗: At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).
Changes in HbA1c levels (%) from baseline.
Excess weight loss
时间窗: At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).
Changes in percentage of excess weight loss from baseline.
次要结局
- C-peptide(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Proportion of subjects losing more than 50% of baseline excess weight(At visit 1 (Baseline), visit 5 (12 months after bariatric surgery).)
- Caseinolytic protease B(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Insulin(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- LDL cholesterol(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Triacylglycerides(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Gut microbiota(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Gastrointestinal quality of life(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Gut microbiota metabolites(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Total cholesterol(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Free fat mass(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Fasting blood glucose(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- HDL cholesterol(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)
- Body fat mass(At visit 1 (Baseline), visit 2 (3 months after bariatric surgery), visit 3 (6 months after bariatric surgery), visit 4 (9 months after bariatric surgery), visit 5 (12 months after bariatric surgery).)