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The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.

RecruitingNAAges 50 Years - 80 YearsAllHull University Teaching Hospitals NHS Trust
NCT07483502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 agains

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📋 Eligibility rules (as published)
INCLUSION CRITERIA: * 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. EXCLUSION CRITERIA * 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
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What it tests

  • 5g of prebiotic fibre and 300mg of magnesium (WellBiome)
  • 5g of maltodextrin
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Where

1 site
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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