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ENERGISEDNCT07300553

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below.

  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 2026 to Nov 2026
    • Start date changed from estimate of Dec 2025 to Jan 2, 2026
    • Site details revised
    v2
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Evaluate the impact of the gut microbiota, and of its alteration in inflammatory bowel disease, on peripheral immune cells energy metabolism
Timeframe: Healthy volunteers : 7 days/ IBD patients : 1 day

Secondary (2)

Evaluate the impact of the gut microbiota and its alteration in inflammatory bowel disease on the fate of microbiota-derived carbon sources in host cells
Identify the intestinal bacteria involved in this process

Arms and interventions

Healthy volunteersExperimental

Healthy volunteer will be seen by a physician from the CRC-Est in LRIPH Saint-Antoine to verify their eligibility and collect their written consent. The baseline visit (V1) takes place within 4 weeks after the inclusion visit (V0). Antimicrobial treatment will be provided to the participant (7/8 days treatment). V2 takes place 7 days after baseline visit after the antimicrobial treatment For each visit (V1 and V2) the participants will be seen by a research physician and nurse after an overnight fast. Blood sample (for SCENITH analysis) will be perfomed. Then, participants will receive a standard breakfast with 10g 13C-labeled inulin, which serves as a model fermentable substrate. Blood samples (8mL) will be then collected every hour between 2 and 10h after consumption of the breakfast. All urines and stool samples emitted during the day D0 will be collected (and time recorded). Follow up at D2 to D3 post V1 will be done by a phone interview by CRT or nurse with the help and validati

Patients with IBDExperimental

IBD patients will be seen by a gastroenterologist from the Gastroenterology department of the Saint-Antoine hospital or physician from the CRC-Est in LRIPH or the gastroenterology department of Saint Antoine to verify their eligibility, and collect their written consent during a usual follow up visit. The baseline visit (V1) takes place within 4 weeks after the inclusion visit (V0). The patients will be seen by a research physician and nurse after an overnight fast. Blood sample (for SCENITH analysis) will be perfomed. Then, participants will receive a standard breakfast with 10g 13C-labeled inulin, which serves as a model fermentable substrate. Blood samples (7mL) will be then collected every hour between 2 and 10h after consumption of the breakfast. All urines and stool samples emitted during the day D0 will be collected (and time recorded). The patient will also receive a kit for fecal collection at home to be done the day before v1.

Drugs: Vancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg

Dietary supplements: Inulin/Inulin C13

Sites

1 site in 1 country

  • Gastroenterology Department Saint Antoine Hospital,Paris, France