Cardiovascular Diseases (CVD)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.
A study testing 5g of prebiotic fibre and 300mg of magnesium (WellBiome) and 5g of maltodextrin in people with Cardiovascular Diseases (CVD) and Cardiovascular Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cardiovascular Diseases (CVD), Cardiovascular Surgery
- What is being tested?
- 5g of prebiotic fibre and 300mg of magnesium (WellBiome) and 5g of maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2026to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, East Riding Of Yorkshire, HU16 5JQ
James Philip Hobkirk, PhD, +44 (0) 7894264660, james.hobkirk3@nhs.net
Mahmoud Loubani, MD, mahmoud.loubani@nhs.net
About this study
Official 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.
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.
Read more
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.
- Being tested
- 5g of prebiotic fibre and 300mg of magnesium (WellBiome), 5g of maltodextrin
- Keywords
- Cardiac surgery, Surgical outcomes, Nutritional prehabilitation, Microbiome
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5g of prebiotic fibre and 300mg of magnesium (WellBiome)Dietary supplement
5g of prebiotic fibre and 300mg of magnesium (WellBiome)
5g of maltodextrinDietary supplement
A matched placebo of 5g maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A matching placebo containing 5g of maltodextrin Receives: Dietary Supplement: 5g of maltodextrin |
| Experimental | Experimental | A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME) Receives: Dietary Supplement: 5g of prebiotic fibre and 300mg of magnesium (WellBiome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU time (hours)
- 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
Measured: 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
Measured: Number of complications following cardiac surgery, up to 30 days.
Length of hospital stay (days)
Length of hospital stay from admission to medical discharge
Measured: From hospital admission until hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start9 Apr 2026
- Primary completion28 Oct 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483502
- Sponsor's protocol ID
- 2705622
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07483502
- Acronym / sponsor ID
- 2705622
- Keywords
- Cardiac surgery, Surgical outcomes, Nutritional prehabilitation, Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: 5g of maltodextrinA matching placebo containing 5g of maltodextrin |
| Experimental | Experimental | Dietary Supplement: 5g of prebiotic fibre and 300mg of magnesium (WellBiome)A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5g of prebiotic fibre and 300mg of magnesium (WellBiome)5g of prebiotic fibre and 300mg of magnesium (WellBiome) | Dietary supplement | Experimental |
| 5g of maltodextrinA matched placebo of 5g maltodextrin | Dietary supplement | Placebo |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5g of prebiotic fibre and 300mg of magnesium (WellBiome) and 5g of maltodextrin in people with Cardiovascular Diseases (CVD) and Cardiovascular Surgery, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Philip Hobkirk, PhD (+44 (0) 7894 264660, james.hobkirk3@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU time (hours) (time frame: From ICU admission until ICU discharge, up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.