RecruitingNot ApplicableNCT07483502

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

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.


Sponsor

Hull University Teaching Hospitals NHS Trust

Enrollment

80 participants

Start Date

Apr 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 5g of maltodextrin and 5g of prebiotic fibre and 300mg of magnesium (WellBiome) for people with cardiovascular diseases (cvd) and cardiovascular surgery. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENT5g of prebiotic fibre and 300mg of magnesium (WellBiome)

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

DIETARY_SUPPLEMENT5g of maltodextrin

A matched placebo of 5g maltodextrin


Locations(1)

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07483502


Related Trials