6-week gut microbiome prep before heart surgery to see if it improves outcomes and saves NHS costs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial examines whether a prebiotic fiber plus magnesium (WellBiome) given for six weeks before cardiac surgery can improve surgical outcomes compared with a placebo. Participants are adults aged 50–80 with certain BMI and waist criteria who are awaiting procedures like bypass or valve replacement. The study uses a double-arm design with 5 g of prebiotic fiber and 300 mg magnesium versus 5 g maltodextrin as a control, aiming to modulate the gut microbiome prior to surgery. Outcomes of interest include postoperative recovery, inflammatory responses, immune function, and cost implications for the NHS. The trial is conducted at Hull University Teaching Hospitals NHS Trust and is led by the sponsor institution.

Why it matters

Who can join: the full rules

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

Where it's running

• Hull University Teaching Hospitals NHS Trust
  Hull, East Riding Of Yorkshire, United Kingdom Recruiting

Study contacts

• Study coordinator: James Philip Hobkirk, PhD
• Email: james.hobkirk3@nhs.net
• Phone: +44 (0) 7894 264660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.