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Not yet recruitingNAINTERVENTIONAL

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

This study investigates if a supplement taken before heart surgery can improve recovery. Many people are waiting for surgery, and this research is part of a bigger plan to help patients prepare better. Heart surgery, while life-saving, puts stress on the body. Inside your gut, trillions of bacteria (your gut microbiome) play a vital role in healing and immunity. This trial is exploring whether improving these gut bacteria with a daily supplement of prebiotic fibre and magnesium before surgery can lead to faster recovery, less time in intensive care, shorter hospital stays, and fewer problems. We're comparing this supplement (WellBiome) to a dummy pill (placebo) over 6-8 weeks before surgery.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Hull University Teaching Hospitals NHS Trust
Enrolment target
80
Start
02 Mar 2026
Estimated completion
18 Dec 2026

What is this study about?

Imagine you're getting ready for a big race. You'd probably train, eat well, and prepare your body, right? In a similar way, this research is about 'prehabilitation' – getting your body ready before surgery. For many people, preparing for heart surgery is a big deal, and this study aims to see if we can help your body be in the best possible shape for it.

When you have heart surgery, it's like your body goes through a carefully managed period of stress. This can cause inflammation and put demands on your immune system, which then needs to work hard to help you heal. What might surprise you is that the billions of tiny bacteria living in your gut – your gut microbiome – play a huge role in how your body handles this stress, manages inflammation, and fights off infections.

This study is asking a really interesting question: can we give your gut bacteria a helping hand with a special fibre and magnesium supplement (called WellBiome) in the weeks leading up to your surgery? Researchers hope this could help you recover faster, spend less time in intensive care, get home sooner, and have fewer complications after your heart operation. We're comparing WellBiome to a dummy pill (a placebo) to see if these improvements really come from the supplement itself.

Key takeaways

  • This study explores how a specific supplement before heart surgery might boost recovery.
  • It focuses on the gut microbiome's role in healing and immunity.
  • Participants will take either WellBiome (fibre and magnesium) or a dummy pill for 6-8 weeks before surgery.
  • Researchers will track recovery time, hospital stay duration, and complications.
  • The aim is to see if improving gut health can lead to better surgical outcomes and potentially save NHS costs.

Who may be eligible?

To join this study, you would need to be between 50 and 80 years old. Your Body Mass Index (BMI) should be between 25 and 40, and your waist measurement would also be checked. We'd also look at your blood sugar levels (HbA1c) to ensure they are within a specific range.

There are also some important things that would mean you couldn't take part. For example, if you have active cancer, or if you've had certain gut surgeries or significant digestive problems like Crohn's disease or ulcerative colitis. You also couldn't have taken antibiotics in the last three months, or regularly use certain pain relief medications like ibuprofen, or stomach acid reducers such as Omeprazole, within specific timeframes. If you're already taking other prebiotics or probiotics, or if you are vegetarian or vegan, you wouldn't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Am I between 50 and 80 years old?
  2. Do I have a BMI between 25 and 40 (or a waist measurement over 94cm for men, 88cm for women)?
  3. Have I avoided taking antibiotics in the last 3 months?
  4. Do I currently have active cancer, or significant digestive conditions like Crohn's or ulcerative colitis?
  5. Have I avoided proton pump inhibitors (like Omeprazole) or regular ibuprofen in the last month?
  6. Am I willing to provide blood, urine, and stool samples?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly put into one of two groups, like flipping a coin. One group will take the WellBiome supplement, and the other will take a dummy pill (maltodextrin). You wouldn't know which one you're taking, and neither would the research team, until the end of the study. You would take 5 grams of your assigned supplement every day for 6 to 8 weeks before your heart surgery.

Throughout the study, you'll provide some samples: blood, urine, and stool (poo) samples at the very beginning, and another set when you come into the hospital for your surgery. After your surgery, you'll give two more blood samples, one around three days later and another around six days later. The study team will also keep track of how long you stay in intensive care, your overall hospital stay, and any complications you might have.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as a faster recovery, shorter hospital stay, or fewer complications after your heart surgery. However, there's no guarantee that you will experience these benefits. As with any study involving supplements, there's a small chance of side effects, although the ingredients are generally considered safe. You would be fully informed of any known risks during the consent process. Taking part is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and this would not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Hull University Teaching Hospitals NHS Trust
    Verified postcode
    Hull, United Kingdom

Common questions

What is 'prehabilitation'?

It means preparing your body before surgery to help you recover better afterwards. Think of it like training for an event.

What is the 'gut microbiome'?

It's the collection of trillions of tiny bacteria living in your intestines that help with digestion, immunity, and overall health.

What's the difference between WellBiome and the placebo?

WellBiome contains special fibre and magnesium, while the placebo is a dummy pill (maltodextrin) that looks and tastes similar but has no active ingredients.

Will I know which supplement I'm taking?

No, this is a 'blinded' study, meaning neither you nor the research team will know which you're taking until the study is over.

What kind of samples will I need to give?

You'll provide blood, urine, and stool (poo) samples at specific times before and after your surgery.

How to find out more

James Philip Hobkirk, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "The Effects of a 6-week Pre-operative Administration of a Mi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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