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Clinical Trial NCT07483502 for Cardiovascular Diseases (CVD), Cardiovascular Surgery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings. 80 Microbiome Placebo-Controlled
Clinical Trial NCT07483502 is an interventional study for Cardiovascular Diseases (CVD), Cardiovascular Surgery and is currently not yet recruiting. Enrollment is planned to begin on 2 March 2026 and continue until the study accrues 80 participants. Led by Hull University Teaching Hospitals NHS Trust, this study is expected to complete by 18 December 2026. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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 rep...
Show MoreOfficial 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.
Conditions
Cardiovascular Diseases (CVD)Cardiovascular SurgeryOther Study IDs
- 2705622
NCT ID Number
Start Date (Actual)
2026-03-02
Last Update Posted
2026-03-23
Completion Date (Estimated)
2026-12-18
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Cardiac surgery
Surgical outcomes
Nutritional prehabilitation
Microbiome
Surgical outcomes
Nutritional prehabilitation
Microbiome
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorPlacebo A matching placebo containing 5g of maltodextrin | 5g of maltodextrin A matched placebo of 5g maltodextrin |
ExperimentalExperimental A microbiome modulator containing 5g of prebiotic fibres and 300mg of magnesium (WELLBIOME) | 5g of prebiotic fibre and 300mg of magnesium (WellBiome) 5g of prebiotic fibre and 300mg of magnesium (WellBiome) |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
- 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.
- 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
Hull University Teaching Hospitals NHS TrustStudy Central Contact
Contact: James Philip Hobkirk, PhD, +44 (0) 7894 264660, [email protected]
1 Study Locations in 1 Countries
East Riding Of Yorkshire
Hull University Teaching Hospitals NHS Trust, Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
James Philip Hobkirk, PhD, Contact, +44 (0) 7894264660, [email protected]
Mahmoud Loubani, MD, Contact, [email protected]