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NCT Number: NCT07483502

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

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.

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

5g of maltodextrin

Dietary Supplement

A matched placebo of 5g maltodextrin

Primary outcomes

  1. ICU time (hours)

    Time frame: From ICU admission until ICU discharge, up to 30 days

    • 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

  2. Complications post cardiac surgery

    Time frame: Number of complications following cardiac surgery, up to 30 days.

    The number of Society of Cardio-thoracic Surgery register of complications

  3. Length of hospital stay (days)

    Time frame: From hospital admission until hospital discharge, up to 30 days

    Length of hospital stay from admission to medical discharge

Study contacts

Contact information is provided by the study sponsor or research team.

James Philip Hobkirk, PhD

CONTACT

[email protected]

+44 (0) 7894 264660

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jun 23, 2026

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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