RecruitingNAINTERVENTIONAL

Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease

This research is investigating whether taking a fibre called inulin can help people with advanced kidney disease. Sometimes, people with kidney disease don't get enough fibre, which can affect the helpful bacteria in their gut. This study aims to understand if taking inulin for 35 days can improve the balance of these gut bacteria, strengthen the gut's natural protective barrier, and influence important immune cells in the body. We hope to learn more about how dietary fibre might support the health of individuals living with chronic kidney disease.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

01 Feb 2022

Estimated completion

01 Feb 2027

Chronic Kidney Disease 5D

What is this study about?

When you have kidney disease, especially an advanced form (like stage 5D), your body's needs change. It can sometimes be hard to get all the nutrients you need, including enough fibre. Fibre is really important for a healthy gut, where billions of tiny bacteria live. These bacteria, often called your 'gut microbiome,' play a big role in your overall health.

This study is looking at a specific type of fibre called inulin. We want to see if taking inulin as a supplement can help improve the health of the gut microbiome in people with advanced kidney disease. A healthy gut microbiome can help with digestion and even affect your immune system.

We're also interested in how inulin might affect the 'gut barrier.' Think of this as the protective lining of your gut. If it's strong, it helps prevent unwanted substances from reaching your bloodstream. By understanding these effects, the study hopes to find new ways to support the health of people living with chronic kidney disease.

Key takeaways

This study explores how a fibre called inulin affects gut health in people with advanced kidney disease.
It aims to improve gut bacteria balance, strengthen the gut lining, and affect immune cells.
Participants will take either inulin or a placebo for 35 days.
Results could help improve care for people with chronic kidney disease.
Your regular medical care will not be affected if you join or leave the study.

Who may be eligible?

To take part in this study, you need to be a man or woman between 18 and 75 years old. Your Body Mass Index (BMI), which is a measure relating your weight to your height, should generally be between 18.5 and 39.9. Most importantly, you must have advanced kidney disease and have been regularly receiving haemodialysis treatment for at least three months.

There are also some reasons why you wouldn't be able to join. For example, if you have certain serious illnesses like cancer, or if you've recently been in hospital or had surgery. You also can't participate if you have an active infection, are malnourished, or have taken antibiotics in the last four weeks. If you regularly take probiotic or prebiotic supplements, you wouldn't be suitable either, nor if your weight has changed by more than 2kg in the last month, or if you have known drug or alcohol problems.

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 between 18 and 75 years old?
Do you have advanced kidney disease and receive regular haemodialysis for at least 3 months?
Do you rarely take probiotics or prebiotics?
Have you *not* had antibiotics in the last 4 weeks?
Have you *not* been in hospital recently or had surgery?
Do you *not* have an active infection or cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to take a supplement every day for 35 days. For the first 7 days, you'll take half the usual dose (15 grams per day) to help your body adjust, and then you'll take the full dose for the remaining 28 days. You will either receive the inulin supplement or a placebo, which looks identical but contains no active ingredient. You won't know which one you're taking.

During the study, there will be visits where we'll collect samples such as blood and stool samples, and we might ask you to complete questionnaires about your health and diet. These assessments will help us understand the effects of the supplement. The total length of your involvement in the study, including all visits and the supplement period, will be a few weeks.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as we hope to understand if inulin can improve gut health in people with kidney disease. While we can't promise direct health improvements for you, the information we gather could help many other patients in the future. As with any study, there might be some minor risks, such as mild stomach upset from the fibre – these will be carefully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Experimental and Clinical Research Center
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is inulin?

Inulin is a type of natural fibre that is found in many plants, like chicory root, onions, and bananas. It works as a 'prebiotic,' which means it helps feed the good bacteria in your gut.

What is a 'gut microbiome'?

Your gut microbiome is the community of all the tiny bacteria and other microbes that live in your digestive system. They play a really important role in your health, including digestion and your immune system.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real treatment but doesn't contain any active ingredients. In this study, some people will get inulin and others will get a placebo, so we can fairly compare the effects.

How long will I be involved?

You will take the supplement for a total of 35 days. There will also be a few visits for assessments before, during, and after this period.

Will I know if I'm getting the inulin or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving inulin or the placebo until after the study is complete. This helps ensure the results are unbiased.

How to find out more

Victoria McParland, PhD

victoria.mcparland@charite.de +49 30 450 540 464 Official trial record

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