RecruitingPhase 2NCT07300553

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

45 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Inflammatory Bowel Disease (IBD) often leads to poor disease control and reduced quality of life. Changes in the gut microbiota may disrupt the energy metabolism of immune cells, contributing to IBD. This study will examine how gut microbiota affects immune cell metabolism in healthy adults and IBD patients. Healthy volunteers will be tested before and after a short antibiotic treatment, while IBD patients will be tested once. Energy metabolism will be measured using SCENITH, a method that analyzes metabolic activity in blood immune cells. Participants will also receive a special form of fiber (13C-labeled inulin) to track how gut bacteria break down and use this nutrient. Blood, urine, and stool samples will be analyzed to follow the metabolic fate of inulin. DNA and RNA from stool will be studied to identify which bacteria metabolize the labeled fiber.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how the bacteria living in your gut (the gut microbiome) affect how your body's cells produce and use energy. Researchers will compare healthy volunteers with patients who have inflammatory bowel disease (IBD) — conditions like Crohn's disease or ulcerative colitis — to understand the relationship between gut bacteria and cellular metabolism. **You may be eligible if you are a healthy volunteer and...** - You are between 18 and 50 years old - You have a healthy body weight (BMI between 17 and 25 kg/m²) - You are using an effective form of contraception (if you are a woman of childbearing age) **You may NOT be eligible if...** - You have a chronic illness, including IBD, diabetes, or other metabolic conditions - You have taken antibiotics recently - You are pregnant or planning to become pregnant during the study - You do not meet the BMI requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg

7 days treatment taken over 8 calendar days). The first intake will take place just before leaving the hospital on the evening of day 0. A precise schedule will be provided for the antibiotics intakes, with the last intake in the afternoon on day 7 (on day 7, only 3 intakes of antibiotics: morning, noon and afternoon): Vancomycin VIATRIS 500 mg for injection or oral administration Dose: 250mg x4 daily orally Amphotericin B (Fungizone®) Bottle 10% (4000mg/40ml) oral solution Dose 500mg x4 (20ml) daily orally Gentamycine 80 mg/2 ml solution (hospital compounding) Dose 80mg x4 daily orally

DIETARY_SUPPLEMENTInulin/Inulin C13

\- INULIN ; food grade inulin from Chicory (2% labelled with 13C) at H0 on day 0 (v1) and day 7 (v2) for healthy adults and day 0 (v1) only for patients with IBD.


Locations(1)

Gastroenterology Department Saint Antoine Hospital,

Paris, France

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NCT07300553


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