A Double Blind, Placebo Controlled 6- Week Pre-operative Randomised Clinical Trial of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- ICU time (hours)
研究概览
简要总结
More than 7.4 million people in the UK are currently waiting for surgery. Behind that number are real people-patients preparing mentally and physically for procedures ranging from joint replacements to major heart and abdominal operations.
This research forms part of a broader strategy known as prehabilitation - preparing the body before surgery to improve outcomes afterward. For patients waiting for surgery, it represents a shift from passive waiting to active preparation.
Heart surgery for bypass or valve replacements results in inevitable yet controlled trauma. It increases inflammation, stress hormones and immune system demand. The body then has to repair itself - quickly and efficiently. And here's the surprising part. Inside your gut live trillions of bacteria - called your gut microbiome. These bacteria help regulate inflammation, strengthen your immune system and protect against infection.
This randomised clinical trial is investigating a fascinating question:
Can improving your gut microbiome through consumption of fibre before surgery help you recover faster, reduce time in ICU, shorten hospital stays, and lower complication rates? The placebo controlled trial will randomise 80 patients following eligibiilty checks to either 5g of prebiotic fibre/300mg of magnesium (WellBiome) OR 5g of maltodextrin for a period of 6-8 weeks prior to surgery. Patient will provide blood, urine and faecal samples at baseline and upon admission for surgery, and two further blood samples at day 3 and 6 post operatively.
Following surgery, patient outcomes will be assessed and compared between the experimental group (prebiotic fibre/magnesium) and placebo group (maltodextrin). The investigators are focussing on the time spent in the intensive care unit, complications and overall hospital stay. By documenting and quantifying these the investigators can calculate the costs and any savings between the groups.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50-80
- •BMI ≥ 25-40kg/m²
- •Waist circumference >94cm (men) and 88cm (women)
- •HbA1c 42-58 mmol/mol (6.0-7.5 old HbA1c units)
- •No known intolerances to oligosaccharides and xylooligosaccharides
- •Be stable dose of cholesterol and blood pressure medication for 3 months
- •Be willing to participate and sign to that effect.
排除标准
- •Active cancer
- •Any gastro-intestinal surgery or currently under the care of the GI clinical team for any clinically significant digestive issue (Crohn's, IBS, ulcerative colitis).
- •On or had antibiotic treatment in the last 3 months.
- •Patients who have taken ibuprofen in the last week or any condition that increases the likelihood of regular or sustained use during the intervention.
- •On proton pump inhibitors (Omeprazole, Esomeprazole, Lansoprazole, Rabeprazole, Pantoprazole) within the last one month on long acting non-steroidal anti-inflammatory drugs in the last month or any condition that increases the likelihood of regular use during the intervention.
- •Taking any prebiotic or probiotic supplementation within the last three months
- •Patients who are vegetarians or vegans
研究组 & 干预措施
Placebo
A matching placebo containing 5g of maltodextrin
干预措施: 5g of maltodextrin (Dietary Supplement)
Experimental
A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME)
干预措施: 5g of prebiotic fibre and 300mg of magnesium (WellBiome) (Dietary Supplement)
结局指标
主要结局
ICU time (hours)
时间窗: From ICU admission until ICU discharge, up to 30 days
1\. Time in ICU (hours) The total time in hours spent in the ICU, calculated from ICU admission following cardiac surgery to ICU discharge to the general cardiology ward
Complications post cardiac surgery
时间窗: Number of complications following cardiac surgery, up to 30 days.
The number of Society of Cardio-thoracic Surgery register of complications
Length of hospital stay (days)
时间窗: From hospital admission until hospital discharge, up to 30 days
Length of hospital stay from admission to medical discharge
次要结局
未报告次要终点