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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A matching placebo containing 5g of maltodextrin |
|
| Experimental | Experimental | A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5g of prebiotic fibre and 300mg of magnesium (WellBiome) | Dietary Supplement | 5g of prebiotic fibre and 300mg of magnesium (WellBiome) |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICU time (hours) | 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 | From ICU admission until ICU discharge, up to 30 days |
| Complications post cardiac surgery | The number of Society of Cardio-thoracic Surgery register of complications | Number of complications following cardiac surgery, up to 30 days. |
| Length of hospital stay (days) | Length of hospital stay from admission to medical discharge | From hospital admission until hospital discharge, up to 30 days |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Philip Hobkirk, PhD | Contact | +44 (0) 7894 264660 | james.hobkirk3@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull University Teaching Hospitals NHS Trust | Recruiting | Hull | East Riding Of Yorkshire | HU16 5JQ | United Kingdom |
We will share the clinical study report and derived data with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study steering committee.
Starting 6 months following publication and ending 5 years after publication.
Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study steering committee.
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| 5g of maltodextrin | Dietary Supplement | A matched placebo of 5g maltodextrin |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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