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Active not recruitingNAINTERVENTIONAL

The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL

This study, called RECLAIM-GUT, explores the important link between the tiny living organisms in your gut (your "gut microbiome") and things like cravings and the risk of going back to old habits. Our gut contains billions of these microbes, which are vital for our health, digestion, and even our mood. When this balance is disturbed, it can affect many parts of our body, including how our brain works. This research project is testing three different personalized prebiotic supplements. Prebiotics are special fibres that help the good bacteria in your gut grow. The study aims to see if targeting and improving your gut health with these personalized supplements can have a positive impact. It will enrol healthy adults who drink alcohol moderately to understand this connection better.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University of Roehampton
Enrolment target
20
Start
10 Dec 2025
Estimated completion
15 Jun 2026

What is this study about?

You might have heard about the 'gut microbiome' – it's basically the community of trillions of tiny living things, like bacteria, that live inside your intestines. These tiny helpers play a huge role in keeping you healthy, from digesting your food to supporting your immune system and even influencing your mood. Think of it like a bustling inner garden; when it's balanced, everything thrives.

Sometimes, this balance can get upset, perhaps due to diet, lifestyle, or even alcohol use. When this happens, it's called 'dysbiosis,' and it's been linked to various health issues, including problems with mood and cravings. Medical science is still learning a lot about how our gut talks to our brain, but we know there's a strong connection. This study is exploring a way to help restore that balance using something called 'prebiotics.' These are specific types of fibre that act like food for the good bacteria already in your gut, helping them grow and flourish.

The RECLAIM-GUT trial is looking into how supporting your gut health with personalized prebiotics could make a difference. The idea is that if we can make your gut healthier, it might positively affect cravings and overall well-being. Researchers are particularly interested in moderate alcohol users to understand this link better. They're also using a new method to get a very detailed picture of each person's unique gut microbes, so they can tailor the prebiotic support.

Key takeaways

  • Exploring the gut-brain connection in moderate alcohol users.
  • Testing personalized prebiotic supplements to improve gut health.
  • No in-person clinic visits required; participation is remote.
  • Involves providing stool samples and taking a daily supplement for 60 days.
  • Aims to understand how gut bacteria influence well-being.
  • Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

For this study, researchers are looking for adults between 18 and 65 years old who live in the UK. You should generally be in good health and not have any serious long-term illnesses, especially those affecting your gut. It's also important that you can read and understand English, as all the study information and consent forms will be in English.

They are specifically looking for people who drink a moderate amount of alcohol, which means more than 14 units or 6 pints per week. You'll need to be happy to provide stool (poo) samples and take a daily prebiotic supplement for about two months. You also need to have internet and email access.

However, you won't be able to join if you have known gut conditions like inflammatory bowel disease (such as Crohn's or colitis) or coeliac disease. If you've recently taken antibiotics (in the last 2-3 months) or regularly used probiotics or prebiotics (in the past month), you also can't take part. Pregnant or breastfeeding women, or anyone with allergies to common ingredients in supplements, are also excluded. Finally, if you're taking special diets or medications that heavily affect your gut bacteria, or if you've been in another clinical trial recently, this study won't be suitable for you.

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. Are you between 18 and 65 years old and live in the UK?
  2. Are you generally healthy with no severe digestive illnesses?
  3. Do you drink more than 14 units or 6 pints of alcohol per week?
  4. Have you avoided antibiotics in the last 2-3 months and other pre/probiotics in the last 4 weeks?
  5. Are you able to provide stool samples and take a daily supplement for about 2 months?
  6. Do you have internet and email access for study instructions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what it would involve: First, you'll provide an electronic consent form and answer some questions about your health and lifestyle. This will be an 'open-label' study, meaning you will know you are receiving an active prebiotic supplement, as there's no dummy treatment (placebo). Over approximately 60 days (around two months), you will need to take a personalized prebiotic supplement every day. During this time, you will be asked to collect and provide stool (poo) samples at specific times, both at the start of the study and after you've been taking the supplement. These samples will help the researchers understand how the friendly bacteria in your gut change. All communication and instructions will be shared via email and the internet, so you won't need to attend physical visits. The total duration of your active involvement in the study will be about two months.

Potential risks and benefits

Participating in this study might offer you a better understanding of your own gut health and how personalized prebiotics could affect it. While prebiotics are generally considered safe, some people might experience mild digestive changes like bloating or gas as their body adjusts. There's no guarantee of direct health benefits for you personally, as this is a research study aimed at gathering information. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Roehampton, School of Life and Health Sciences
    Verified postcode
    London, United Kingdom

Common questions

What is a 'prebiotic'?

Prebiotics are special types of fibre that act like food for the good bacteria already living in your gut, helping them grow and thrive.

Will I know which prebiotic formulation I'm taking?

Yes, this is an 'open-label' study, which means you will know that you are receiving a personalized prebiotic supplement.

Do I need to visit a clinic for this study?

No, this study is managed remotely. All communication and instructions will be online, and you won't need to attend physical appointments.

What happens to the stool samples I provide?

The samples will be carefully analysed to understand the different types of bacteria in your gut and how they change over time with the prebiotic supplement.

Will this study help me stop drinking alcohol?

This study is not designed to help with alcohol reduction, but to understand the link between gut health and moderate alcohol use. It does not offer alcohol cessation treatment.

How to find out more

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

Discussion

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