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

NCT07300553 | Recruiting Phase 2 DMC

• 1 other identifier: APHP221107
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBD; Crohn Disease; Ulcerative Colitis (UC)

Keywords

Energy Metabolism; Gut Microbiota; Healthy volunteers; Patients with IBD; SCENITH analysis; Antimicrobial treatment; Inulin; Biological collection

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of the gut microbiota, and of its alteration in inflammatory bowel disease, on peripheral immune cells energy metabolism

  Energy metabolism of major immune cell types for peripheral blood will be assessed on a blood sample * For healthy adults, this analysis will be performed on blood sample at day 0 (v1, before antimicrobial treatment onset) and at day 7 (v2, last day of the antimicrobial treatment). * For patients with IBD this analysis will be performed on blood sample at day 0 (v1). The energy metabolism will be assessed by single-cell energetic metabolism by profiling translation inhibition (SCENITH) approach (Argüello et al., 2020). SCENITH is a flow cytometry-based approach allowing to functionally profile energy metabolism with single-cell resolution from a simple blood sample

  Healthy volunteers : 7 days/ IBD patients : 1 day

Secondary Outcomes (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

  Healthy volunteers : 7 days/ IBD patient : 1 day

• Identify the intestinal bacteria involved in this process

  Healthy volunteers : 7 months and 8 days/IBD patient : 4 weeks and 2 days

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

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

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

Patients with IBD

EXPERIMENTAL

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.

Dietary Supplement: Inulin/Inulin C13

Interventions

Vancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg DRUG

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

Healthy volunteers

Inulin/Inulin C13 DIETARY_SUPPLEMENT

\- 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.

Patients with IBD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer
• Age ≥ 18 years and \< 50 years
• kg/m² \< body mass index \< 25 kg/m² (microbiota modified based on BMI, (Le Chatelier et al., 2013)
• For women, female of child-bearing age with an active contraception (hormonal, intrauterine device, bilateral tubal occlusion, sexual abstinence\*) and this during at least the period of treatment (up to v2) \*Sexual abstinence is defined as refraining from heterosexual intercourse from providing consent until V3. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant
• A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH), level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
• Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
• Patient with health insurance (AME except)
• Informed Written consent Patient with IBD
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• Age ≥ 18 years and \< 50 years
• Crohn's Disease (Excepting disease involving only the upper GI tract) or ulcerative colitis (excepting disease involving only the rectum), according to the Lennard-Jones criteria for at least 6 months (15 patients with Crohn's disease and 15 with ulcerative colitis will be recruited)
• kg/m² \< body mass index \< 25 kg/m²
• Female of child-bearing age with an active contraception. Efficient contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate \<1%)
• \*\* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
• A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient

You may not qualify if:

• Healthy volunteers :
• Infectious episode requiring antimicrobial treatment since V0
• Severe diarrhea (increase of seven or more stools per day over baseline)
• Patients with IBD - Infectious episode requiring antimicrobial treatment since V0
• \- IBD flare

Sponsors & Collaborators

• INSERMUMR938: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• CRB SAT APHP.SU Saint-Antoine hospital: collaborator

Study Sites (1)

Gastroenterology Department Saint Antoine Hospital,

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Vancomycin; Amphotericin B; Inulin

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Polyketides; Lactones; Organic Chemicals; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Fructans; Polysaccharides

Study Officials

• Harry SOKOL, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry SOKOL, PU-PH

CONTACT

00 33 1 49 28 31 62; harry.sokol@aphp.fr

Mélissa MONTIL, Praticien attaché

CONTACT

00 33 1 71 97 0810; melissa.montil@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)