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Study on How Gut Bacteria Affect Energy Use in Cells for Healthy Adults and Patients with Inflammatory Bowel Disease Using Amphotericin B, Vancomycin, and Gentamicin Sulfate

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the impact of the gut microbiota on energy metabolism in people with and without Inflammatory Bowel Disease (IBD). The study involves healthy adults and patients with IBD who are in remission. IBD is a condition that causes inflammation in the digestive tract, and it includes diseases like Crohn's Disease and ulcerative colitis. The purpose of the study is to evaluate how changes in the gut microbiota affect the energy metabolism of immune cells in the body.

Participants in the study will receive different treatments, including Gentamicin, Amphotericin B, and Vancomycin. These are antibiotics that help fight infections. The study will also involve the use of a placebo. Over the course of the study, participants will take these medications orally for a period of up to seven days. The study will also involve taking blood samples to assess the energy metabolism of immune cells and using a special technique to track how the body processes certain nutrients.

The study aims to provide insights into how the gut microbiota and its changes in IBD affect the body's energy use. This could help improve understanding of IBD and lead to better treatments in the future. Participants will be monitored throughout the study to ensure their safety and to gather important data on how their bodies respond to the treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide written consent to participate in the trial. This consent confirms your understanding of the study and your willingness to participate.

    You will also be asked to confirm your eligibility, which includes being between 18 and 50 years old, having a body mass index (BMI) between 17 and 25, and for women of child-bearing age, using active contraception.

  2. Step 2

    First administration of inulin

    On day 0, you will receive an oral dose of food grade inulin from chicory, which is 2% labeled with a special carbon marker called 13C. This will help in tracking how your body processes the inulin.

    This step is designed to assess how the gut microbiota, the community of microorganisms in your intestines, affects energy metabolism in your body.

  3. Step 3

    Sample collection and analysis

    Blood samples will be collected to evaluate the energy metabolism of your immune cells. This involves analyzing how your cells use energy at a detailed level.

    Fecal samples will also be collected to identify the intestinal bacteria responsible for metabolizing the labeled inulin. This will involve extracting DNA and RNA from the samples for further analysis.

  4. Step 4

    Second administration of inulin for healthy volunteers

    If you are a healthy volunteer, you will receive a second dose of the labeled inulin on day 7. This is to further assess the impact of the gut microbiota on energy metabolism.

    This step is not applicable if you are a patient with inflammatory bowel disease (IBD).

  5. Step 5

    Completion of trial participation

    Your participation in the trial will conclude after the final assessments are completed. This includes the analysis of the collected samples to understand the impact of gut microbiota on energy metabolism.

    The study aims to provide insights into how alterations in gut microbiota affect energy metabolism, particularly in individuals with inflammatory bowel disease.

Who can join the trial?

13 criteria

  • For healthy volunteers: Must be between 18 and 50 years old.
  • For healthy volunteers: Body Mass Index (BMI) must be between 17 and 25. BMI is a measure of body fat based on height and weight.
  • For patients with Inflammatory Bowel Disease (IBD): Must be between 18 and 50 years old.
  • For patients with IBD: BMI must be between 17 and 25.
  • For patients with IBD: Must have regular bowel movements, which means at least 1 stool every other day and no more than 3 stools per day.
  • For patients with IBD: Must have health insurance (except AME).
  • For patients with IBD: Must provide informed written consent, which means you agree to participate after understanding the study.
  • For patients with IBD: Must have either Crohn's Disease or ulcerative colitis for at least 6 months, but not affecting only the upper gastrointestinal tract or only the rectum.
  • For patients with IBD: Must be in steroid-free clinical remission for at least 6 months. This means the disease is not active and you are not taking steroids.
  • For women of child-bearing age: Must use active contraception, such as hormonal methods, intrauterine devices, or other reliable methods, during the study period.
  • For healthy volunteers: Must have regular bowel movements, which means at least 1 stool every other day and no more than 3 stools per day.
  • For healthy volunteers: Must have health insurance (except AME).
  • For healthy volunteers: Must provide informed written consent, which means you agree to participate after understanding the study.

Who cannot join the trial?

4 criteria

  • Individuals with a history of gastrointestinal disease cannot participate. This means any past issues with the stomach or intestines.
  • Participants must not have any current symptoms of inflammatory bowel disease (IBD). IBD is a condition that causes inflammation in the digestive tract.
  • Only healthy adults with no history of gastrointestinal disease are eligible.
  • Participants must be in remission if they have IBD. Remission means that the disease is not currently active or causing symptoms.
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Investigated drugs

{ "authorizedApplication.authorizedPartI.products.0": [ { "productName": "FMT", "description": "Fecal Microbiota Transplantation (FMT) is a procedure where stool from a healthy donor is transferred into the gastrointestinal tract of a patient. This is done to introduce beneficial bacteria into the patient's gut, which can help restore a healthy balance of gut bacteria. In this trial, FMT is being used to study its effects on energy metabolism in people with inflammatory bowel disease." }, { "productName": "Probiotic Supplement", "description": "A probiotic supplement contains live beneficial bacteria that are similar to the ones naturally found in the human gut. These supplements are taken to help improve or restore the natural balance of gut bacteria. In this trial, the probiotic supplement is being used to see how it affects energy metabolism in the body, especially in people with inflammatory bowel disease." } ] } FMT is a procedure where stool from a healthy donor is transferred into the gastrointestinal tract of a patient. This is done to introduce beneficial bacteria into the patient's gut, which can help restore a healthy balance of gut bacteria. In this trial, FMT is being used to study its effects on energy metabolism in people with inflammatory bowel disease. Probiotic Supplement contains live beneficial bacteria that are similar to the ones naturally found in the human gut. These supplements are taken to help improve or restore the natural balance of gut bacteria. In this trial, the probiotic supplement is being used to see how it affects energy metabolism in the body, especially in people with inflammatory bowel disease.

What is already known about the treatment

Gut Microbiota Modulator – This medication is administered orally and works by influencing the gut microbiota, which is the community of microorganisms living in the digestive tract. It is currently being studied in clinical trials to understand its effects on energy metabolism in immune cells, particularly in healthy adults and patients with inflammatory bowel disease (IBD) in remission. The main therapeutic indication is to explore its potential benefits in managing IBD by altering gut microbiota composition. At the molecular level, it is believed to modulate the activity of gut bacteria, which in turn affects the energy metabolism of immune cells. This medication falls under the pharmacological classification of microbiome modulators, which are substances designed to alter the composition or function of the gut microbiota.

Investigated diseases

Inflammatory Bowel Disease (IBD) – Inflammatory Bowel Disease is a chronic condition that involves inflammation of the digestive tract. It primarily includes two types: Crohn's disease and ulcerative colitis. In Crohn's disease, inflammation can occur anywhere along the digestive tract, often affecting deeper layers of the bowel. Ulcerative colitis, on the other hand, is limited to the colon and rectum, affecting only the innermost lining. The inflammation in IBD can lead to symptoms such as abdominal pain, diarrhea, and fatigue. Over time, the inflammation can cause damage to the digestive tract, leading to complications such as strictures or fistulas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513330-38-00Protocol codeAPHP221107Estimated enrolment45 patientsSponsorAssistance Publique Hopitaux De Paris

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