RecruitingPHASE2INTERVENTIONAL

Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease

This research is investigating how the tiny living organisms in our gut, called the gut microbiota, affect how our body’s cells get energy. We're particularly interested in healthy people and those with conditions like Crohn's disease and ulcerative colitis, which are types of Inflammatory Bowel Disease (IBD). IBD can severely impact quality of life, and we believe changes in gut germs might be involved in how immune cells get their energy, potentially making IBD worse. Healthy volunteers will receive a short course of antibiotics before tests. People with IBD will have tests once. We will use a special method to measure energy use in blood immune cells. Participants will also receive a special type of fibre, and we will track how their gut germs break it down using blood, urine, and stool samples. This helps us learn which germs are involved. Ultimately, this study aims to shed light on how our gut germs play a role in energy metabolism, which could lead to better ways of managing IBD in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

02 Jan 2026

Estimated completion

01 Aug 2027

IBD Crohn Disease Ulcerative Colitis (UC)

What is this study about?

Imagine your body as a busy city, and your cells are like tiny factories that need energy to work properly. This study is all about understanding how the microscopic living creatures in your gut – often called gut microbiota or gut germs – influence how these 'factories' (especially your immune cells) get their energy. We're focusing on this because people with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis, often have problems with their immune system and struggle with symptoms that affect their daily lives. We suspect that changes in these gut germs might be playing a role in disrupting how immune cells get their energy.

The main goal of this research is to see if there's a link between your gut germs and the energy use of your immune cells, both when you're healthy and when you have IBD. If we can better understand this connection, it could open doors to new ways of helping people with IBD feel better and manage their condition more effectively. This is a "Phase 2" study, which means it builds on earlier research and aims to gather more detailed information about how these processes work in the body.

To do this, we'll be looking at two main groups of people: healthy volunteers and patients who have either Crohn's disease or ulcerative colitis. The healthy volunteers will have some tests, followed by a short course of antibiotics to temporarily change their gut germs, and then more tests. This helps us see how changing the germs affects their energy metabolism. Patients with IBD, on the other hand, will go through the testing once. We will also give participants a special type of fibre (called 13C-labeled inulin) and then check their blood, urine, and stool samples to see how their gut germs break down and use this fibre. By doing this, we hope to identify which specific germs are involved in these important energy processes. All the information we gather will help us piece together the puzzle of how gut germs, energy, and IBD are connected.

Key takeaways

The study explores how gut germs affect energy in immune cells.
It involves healthy people and those with Crohn's disease or ulcerative colitis.
Healthy volunteers take a short course of antibiotics; IBD patients are in remission.
Participation includes blood, urine, and stool samples, plus a special fibre.
Aims to improve understanding of IBD for future treatments.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for two main groups of people: healthy volunteers and those with Inflammatory Bowel Disease (IBD).

If you're healthy and interested, you need to be between 18 and 50 years old and have a body mass index (BMI) — a measure of your weight compared to your height — that falls within a healthy range (not too thin, not too heavy). You should also have regular bowel movements (pooing at least every other day, but not more than three times a day). If you're a woman of child-bearing age, you'll need to be using reliable contraception throughout the study, meaning things like hormonal birth control or an IUD. If you choose to rely on not having sex, this needs to be consistent for the study duration.

If you have IBD (Crohn's disease or ulcerative colitis), you must also be between 18 and 50 years old. Your diagnosis should have been made at least six months ago, and importantly, your condition needs to be in remission – meaning you don't have active symptoms – and you should not be taking steroid medication for your IBD for at least six months. We're looking for 15 patients with Crohn's and 15 with ulcerative colitis. Everyone participating also needs to have health insurance and be able to give their written permission to join the 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.

Are you between 18 and 50 years old?
Do you have a healthy weight for your height (BMI between 17 and 25)?
Do you have regular bowel movements (at least every other day, up to 3 times a day)?
If you have IBD, has your condition been in remission (no active symptoms) for at least 6 months without steroid medication?
If you are a woman of child-bearing age, are you using reliable contraception?
Do you have health insurance?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, here’s a general idea of what will happen. The total duration of your involvement could vary, but typically involves a few visits over a few weeks or months. For healthy volunteers, you will have an initial visit, followed by a short course of antibiotics (Vancomycin, Amphotericin B, Gentamicin). After the antibiotics, you will have another set of assessments. If you have IBD, you will usually have one set of assessments.

During your visits, we will ask you to provide several types of samples: blood, urine, and stool samples. These samples will help us understand your body's energy use and how your gut germs are working. You will also be given a special type of fibre, called 13C-labeled inulin, which is safe and helps us track how your gut bacteria break down food. There will be procedures to collect these samples, and you may be asked to fill out questionnaires about how you are feeling.

We will also use a special technique called SCENITH to measure the energy activity in your blood immune cells. You won't be given any new long-term medications as part of this study, but healthy volunteers will take antibiotics for a short period. All procedures will be explained in detail before you agree to take part, and you'll have plenty of opportunities to ask questions.

Potential risks and benefits

Participating in this study might not offer direct health benefits to you, but the information we gather could significantly help us understand IBD better and potentially lead to improved treatments in the future for many patients. As with any study, there are some potential risks. For healthy volunteers, taking antibiotics can sometimes cause temporary side effects like stomach upset or changes in bowel habits. All participants will need to give blood samples, which might cause minor bruising or discomfort. We will clearly explain all known potential risks before you decide to join. It's very important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Gastroenterology Department Saint Antoine Hospital,
Verified postcode
Paris, France· Recruiting

Common questions

What is the 'gut microbiota'?

The gut microbiota refers to all the tiny living organisms, mainly bacteria, that live in your gut. They play an important role in your health.

What is 'energy metabolism'?

Energy metabolism is how your body's cells get and use energy from food to function properly. It's like how a car needs fuel to run.

What is IBD?

IBD stands for Inflammatory Bowel Disease and includes conditions like Crohn's disease and ulcerative colitis, which cause ongoing inflammation in the gut.

Will I have to stop my current IBD medication?

No, if you have IBD and are in remission, you will likely continue your normal medication. Healthy volunteers will take a short course of antibiotics.

What is 'inulin'?

Inulin is a type of fibre found in many plants. In this study, we use a special form of inulin to see how your gut bacteria break it down.

How to find out more

Harry SOKOL, PU-PH

harry.sokol@aphp.fr 00 33 1 49 28 31 62 Official trial record

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