VANCOMYCIN for Inflammatory bowel disease (IBD) in remission | Healthy volunteer

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years and < 50 years with BMI between 17 and 25 kg/m²"}
• {"criterion_text":"- Patients with IBD: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day"}
• {"criterion_text":"- Patients with IBD: Patient with health insurance (AME except)"}
• {"criterion_text":"- Patients with IBD: Informed Written consent"}
• {"criterion_text":"- For volunteers: 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)"}
• {"criterion_text":"- For volunteers: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day"}
• {"criterion_text":"- For volunteers: Patient with health insurance (AME except)"}
• {"criterion_text":"- For volunteers: Informed Written consent"}
• {"criterion_text":"- Patients with IBD: Age ≥ 18 years and < 50 years with BMI between 17 and 25 kg/m²"}
• {"criterion_text":"- Patients with IBD: 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)"}
• {"criterion_text":"- Patients with IBD: 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)."}
• {"criterion_text":"- Patients with IBD: 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%)"}

Exclusion criteria

• {"criterion_text":"- Healthy volunteers: Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration or history of abdominal surgery (except appendectomy)."}
• {"criterion_text":"- Healthy voluteers: contra-indications to the administration of gentamicin (refer to SmPC)"}
• {"criterion_text":"- Healthy volunteers: Participation in any other interventional study"}
• {"criterion_text":"- Healthy volunteers: under legal protection"}
• {"criterion_text":"- Patients with IBD: Pregnant or breastfeeding women"}
• {"criterion_text":"- Patients with IBD: blood donation in the 3 months before the study"}
• {"criterion_text":"- Patients with IBD: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0"}
• {"criterion_text":"- Patients with IBD: probiotics in the month preceding day 0 and during the study"}
• {"criterion_text":"- Patients with IBD: Ileal resection > 50cm or colectomy"}
• {"criterion_text":"- Patients with IBD: Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)"}
• {"criterion_text":"- Patients with IBD: 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"}
• {"criterion_text":"- Healthy volunteers: Curative long-term treatment"}
• {"criterion_text":"- Patients with IBD: Participation in any other interventional study"}
• {"criterion_text":"- Patients with IBD: Patients under legal protection"}
• {"criterion_text":"- Patient with IBD: Diagnosis of ulcerative colitis restricted to the rectum"}
• {"criterion_text":"- Healthy volunteers : Pregnant or breastfeeding women"}
• {"criterion_text":"- Healthy volunteers : blood donation in the 3 months before the study"}
• {"criterion_text":"- Healthy volunteers: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1)"}
• {"criterion_text":"- Healthy volunteers : probiotics in the month preceding day 0 (V1)"}
• {"criterion_text":"- Healthy volunteers: consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0"}
• {"criterion_text":"- Healthy volunteers: abdominal surgery in the past (except for appendectomy)"}
• {"criterion_text":"- Healthy volunteers: allergy against the antibiotics and antifungal treatment used in this study or to their excipients"}
• {"criterion_text":"- Healthy volunteers: fructose intolerance"}
• {"criterion_text":"- Patient with IBD: Fructose intolerance"}

Primary endpoints

• {"endpoint_text":"- Energy metabolism of major immune cell types for peripheral blood will be assessed on a blood sample. The energy metabolism will be assessed by single-cell energetic metabolism by profiling translation inhibition","definition_or_measurement_approach":"Assessed on a blood sample using single-cell energetic metabolism profiling by profiling translation inhibition (SCENITH)"}

Secondary endpoints

• {"endpoint_text":"- Impact of the gut microbiota and its alterations in inflammatory bowel disease on the fate of microbiota-derived carbon sources in host cells: we will use a strategy based on stable isotope probing (SIP). The participants will receive orally 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. The incorporation of 13C in metabolites will then be assessed","definition_or_measurement_approach":"Participants receive 13C-labelled inulin orally (2%) at specified visits; incorporation of 13C into metabolites assessed by metabolomic analysis on blood samples collected hourly from 2 to 10 h post-ingestion (and at J7 for volunteers)"}
• {"endpoint_text":"- Identification of the intestinal bacteria responsible for the metabolism of the labeled inulin: we will use SIP-DNA and SIP-RNA sequencing approaches: DNA and RNA will be extracted from each fecal samples obtained","definition_or_measurement_approach":"DNA and RNA extracted from fecal samples and analysed using SIP-DNA and SIP-RNA sequencing to identify bacteria incorporating 13C-labelled substrate"}

France

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

71

Number Of Sites

2

Number Of Participants

45

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France