Actively Recruiting

Phase 2
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT07300553

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-12

45

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

I

INSERMUMR938

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers aged 18 to under 50 years
  • Body mass index between 17 and 25 kg/m²
  • Women of childbearing potential must use active contraception or practice sexual abstinence during treatment
  • Regular bowel movements with at least one stool every other day and no more than three stools per day
  • Participants must have health insurance (except AME)
  • Informed written consent
  • Patients aged 18 to under 50 years with Crohn's Disease (excluding only upper GI tract involvement) or ulcerative colitis (excluding only rectum involvement) diagnosed for at least 6 months
  • Patients must be in steroid-free clinical remission for at least 6 months
  • Body mass index between 17 and 25 kg/m²
  • Women of childbearing potential must use effective contraception
  • Regular bowel movements with at least one stool every other day and no more than three stools per day
  • Patients must have health insurance (except AME)
  • Informed written consent
Not Eligible

You will not qualify if you...

  • Significant chronic diseases including chronic gastrointestinal diseases, type 1 or type 2 diabetes, and kidney problems
  • Long-term curative treatment
  • Pregnant or breastfeeding women
  • Blood donation within 3 months before study
  • Use of oral antibiotics or antifungal treatment within 3 months before study start
  • Use of probiotics in the month before study start
  • Consumption of low-calorie or special diets (except vegetarian) in the month before study start
  • History of abdominal surgery except appendectomy
  • Allergy to study antibiotics or antifungal or their components
  • Contraindications to gentamicin
  • Participation in another interventional study
  • Patients under legal protection
  • Clinically significant abnormal lab values at screening
  • Infectious episodes requiring antimicrobial treatment since screening
  • Severe diarrhea (increase of seven or more stools per day over baseline)
  • For IBD patients: ileal resection over 50 cm or colectomy
  • Diagnosis of Crohn's disease restricted to upper gastrointestinal tract
  • Diagnosis of ulcerative colitis restricted to rectum
  • Current or recent (last 6 months) stoma or recent intra-abdominal surgery within 3 months
  • IBD flare at time of inclusion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Gastroenterology Department Saint Antoine Hospital,

Paris, France, 75012

Actively Recruiting

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Research Team

H

Harry SOKOL, PU-PH

CONTACT

M

Mélissa MONTIL, Praticien attaché

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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