Hull University Teaching Hospitals NHS Trust
Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
Location status: Recruiting
Location contact
James Philip Hobkirk, PhD
CONTACT
Mahmoud Loubani, MD
CONTACT
NCT Number: NCT07483502
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
Location status: Recruiting
James Philip Hobkirk, PhD
CONTACT
Mahmoud Loubani, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5g of prebiotic fibre and 300mg of magnesium (WellBiome)
A matched placebo of 5g maltodextrin
Time frame: From ICU admission until ICU discharge, up to 30 days
The total time in hours spent in the ICU, calculated from ICU admission following cardiac surgery to ICU discharge to the general cardiology ward
Time frame: Number of complications following cardiac surgery, up to 30 days.
The number of Society of Cardio-thoracic Surgery register of complications
Time frame: From hospital admission until hospital discharge, up to 30 days
Length of hospital stay from admission to medical discharge
Contact information is provided by the study sponsor or research team.
Hull University Teaching Hospitals NHS Trust
Other Gov
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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