Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease
Phase 2 · Testing Vancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg and Inulin/Inulin C13 · 1 site · Assistance Publique - Hôpitaux de Paris
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Vancomycin /Amphotericin B (Fungizone®) /Gentamicine 80 mg (a drug) and Inulin/Inulin C13 (a dietary supplement) to better understand how the disease works. Condition(s) listed: IBD, Crohn Disease and Ulcerative Colitis (UC).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 50
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Healthy volunteer
- Age ≥ 18 years and < 50 years
- 17 kg/m² < body mass index < 25 kg/m² (microbiota modified based on BMI, (Le Chatelier et al., 2013)
Plus 42 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 45 participants are expected to take part.
- Start date: 2026-01-02.
- Main results expected around 2026-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Evaluate the impact of the gut microbiota, and of its alteration in inflammatory bowel disease, on peripheral immune cells energy metabolism (Healthy volunteers : 7 days/ IBD patients : 1 day)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | IBD; Crohn Disease; Ulcerative Colitis (UC) |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Collaborators | INSERMUMR938; CRB SAT APHP.SU Saint-Antoine hospital |
| Enrollment | 45 (estimated) |
| Start date | 2026-01-02 |
| Primary completion (est.) | 2026-11 |
| First posted | 2025-12-24 |
| Last updated | 2026-03-12 |
| Official title | Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT07300553 |
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… - 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.
Full eligibility criteria (from the record)
Inclusion Criteria: Healthy volunteer 1. Age ≥ 18 years and < 50 years 2. 17 kg/m² < body mass index < 25 kg/m² (microbiota modified based on BMI, (Le Chatelier et al., 2013) 3. 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 4. Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day 5. Patient with health insurance (AME except) 6. Informed Written consent Patient with IBD <!-- --> 1. Age ≥ 18 years and < 50 years 2. 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) 3. Patient in steroid-free clinical remission for at least 6 months (for Crohn's disease: CDAI <150 the week before inclusion, for ulcerative colitis: Partial Mayo Clinic score of 0 or 1). 4. 17 kg/m² < body mass index < 25 kg/m² 5. 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 6. Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day 7. Patient with health insurance (AME except) 8. Informed Written consent Non inclusion Criteria: Healthy volunteers 1. Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration 2. Curative long-term treatment 3. Pregnant or breastfeeding women** ** 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. 4. blood donation in the 3 months before the study 5. Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1) 6. probiotics in the month preceding day 0 (V1), 7. consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0 8. abdominal surgery in the past (except for appendectomy) 9. allergy against the antibiotics and antifungal treatment used in this study or to their excipients 10. contra-indications to the administration of gentamicin (refer to SmPC) 11. Participation in any other interventional study 12. Patients under legal protection Patients with IBD <!-- --> 1. Pregnant or breastfeeding women 2. blood donation in the 3 months before the study 3. Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 4. probiotics in the month preceding day 0 and during the study, 5. Ileal resection > 50cm or colectomy 6. Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum) 7. Diagnosis of ulcerative colitis restricted to the rectum. 8. Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion 9. Participation in any other interventional study 10. Patients under legal protection Exclusion Criteria: Healthy volunteers : * Clinically significant abnormal serum/ plasma levels of electrolytes, creatinine, liver enzymes, thyroid stimulating hormone or blood cell count at the biological check-up of the visit v0 (screening and inclusion) * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology Department Saint Antoine Hospital, | Paris | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.