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

March 19, 2026 updated by: Hull University Teaching Hospitals NHS Trust

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
A matching placebo containing 5g of maltodextrin
Dietary supplement: 5g of maltodextrin
A matched placebo of 5g 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)
5g of prebiotic fibre and 300mg of magnesium (WellBiome)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU time (hours)
Time Frame: From ICU admission until ICU discharge, up to 30 days

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
Time Frame: Number of complications following cardiac surgery, up to 30 days.
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)
Time Frame: From hospital admission until hospital discharge, up to 30 days
Length of hospital stay from admission to medical discharge
From hospital admission until hospital discharge, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

October 28, 2026

Study Completion (Estimated)

December 18, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2705622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Starting 6 months following publication and ending 5 years after publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study steering committee.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Surgery

Clinical Trials on 5g of maltodextrin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe