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

NCT07483502 | Recruiting DMC

• 1 other identifier: 2705622
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases (CVD); Cardiovascular Surgery

Keywords

Cardiac surgery; Surgical outcomes; Nutritional prehabilitation; Microbiome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A matching placebo containing 5g of maltodextrin

Dietary Supplement: 5g of maltodextrin

Experimental

EXPERIMENTAL

A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME)

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

Interventions

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

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

Experimental

5g of maltodextrin DIETARY_SUPPLEMENT

A matched placebo of 5g maltodextrin

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Magnesium; maltodextrin

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Central Study Contacts

James Philip Hobkirk, PhD

CONTACT

+44 (0) 7894 264660; james.hobkirk3@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Starting 6 months following publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study steering committee.

Locations

GB (1)