Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.
This study is investigating a new type of probiotic, FX856, in people who are overweight or obese. Many people with these conditions often have mild gut inflammation. Normal probiotics don't work well when there's a lot of iron in the gut, which happens during inflammation. However, FX856 is different because it can grow even in these high-iron conditions. The study will compare FX856 to a dummy pill (placebo) to see if it helps reduce gut inflammation and improve digestive problems. It's a 'crossover' study, meaning participants will try both the probiotic and the dummy pill at different times. The goal is to find a safe and effective way to support gut health.
At a glance
What is this study about?
This study is about understanding how a specific type of 'good bacteria' called FX856 might help people who are overweight or obese. Many individuals in these groups experience mild irritation in their gut. Our guts are home to billions of bacteria, and when these get out of balance, it can lead to problems like inflammation. Conditions like Inflammatory Bowel Disease (IBD), which affects many people in the UK, are often linked to this imbalance.
While regular probiotics (supplements containing good bacteria) are often seen as helpful and safe, they sometimes don't work well when the gut is actively inflamed. This is because inflammation can increase the amount of iron in the gut, and most traditional probiotics can't grow properly in such a high-iron environment. FX856 is different; it's a type of bacteria that can thrive even when there's a lot of iron, meaning it might be more effective in an inflamed gut. It's already available to buy in the UK.
The study will recruit people who are overweight or obese to see if taking FX856 can help reduce signs of gut inflammation and improve their digestive symptoms. Participants will take either FX856 or a dummy pill (placebo) for a period, and then switch to the other. This helps researchers compare the effects of the probiotic directly. We hope this research can show if FX856 is a useful way to support gut health for people experiencing these issues.
Key takeaways
- This study is testing a special probiotic, FX856, for gut health.
- It focuses on people who are overweight or obese and may have gut inflammation.
- FX856 is unique because it can work in high-iron gut environments where others can't.
- Participants will try both the probiotic and a dummy pill (placebo) to compare effects.
- The goal is to find a new way to help reduce gut inflammation and improve digestive symptoms.
- Your safety and comfort are a top priority throughout the study.
Who may be eligible?
To join this study, we are looking for adults who are either overweight or obese. This means if you are 40 years or older, your Body Mass Index (BMI) should be 25 or more. If you are aged between 18 and 39 years, your BMI needs to be 30 or more. You should also eat a mix of plant and animal foods.
There are several reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have a long-term gut illness. We also cannot include you if you are currently taking medications that affect your digestive system, or if you regularly use fibre supplements, probiotics, or prebiotics like Actimel, kefir, or kimchi. It's also important that you don't drink a lot of alcohol daily.
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.
- Are you 18 years or older?
- Do you have a Body Mass Index (BMI) that indicates you are overweight or obese (e.g., BMI 25+ if 40+, or BMI 30+ if 18-39)?
- Do you eat a mix of plant and animal foods?
- Are you NOT pregnant or breastfeeding?
- Are you NOT taking medications that affect your gut, or any fibre/probiotic supplements?
- Do you NOT have a long-term bowel illness?
What does participation involve?
If you take part in this study, you will be asked to take either the study probiotic (FX856) or a dummy pill (placebo) for a certain period. After a break, you will then switch to take the other one. You won't know which one you are taking at any given time. Throughout the study, you will have check-ups and provide samples, such as stool samples, to measure gut inflammation. We will also check your blood for markers of inflammation. The total duration of your involvement in the study will be explained to you in detail by the study team.
Potential risks and benefits
Locations (1)
- Ulster University, Human Intervention Studies UnitVerified postcodeColeraine, United Kingdom
Common questions
What is a probiotic?
Probiotics are live 'good' bacteria and yeasts that are good for your health, especially your digestive system. They're often found in fermented foods or supplements.
What does 'gut inflammation' mean?
Gut inflammation is when the lining of your intestines becomes irritated or swollen. It can cause discomfort and digestive issues.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real probiotic but contains no active ingredients. It helps researchers understand if the real treatment actually works.
Will I know if I'm taking the probiotic or the placebo?
No, this is a 'blinded' study, meaning neither you nor the researchers will know who is taking which until the study is over. This helps ensure fair results.
What is BMI and why is it important for this study?
BMI stands for Body Mass Index, which is a measure that uses your height and weight to estimate if you are underweight, a healthy weight, overweight, or obese. It's important for this study because we are specifically looking at people who are overweight or obese.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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