2024-513330-38-00招募中2 期
Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease (ENERGISED-Clinic)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
Evaluate the impact of the gut microbiota, and of its alteration in inflammatory bowel disease, on peripheral immune cells energy metabolism.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •For volunteers: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 km/m²
- •Patients with IBD: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- •Patients with IBD: Patient with health insurance (AME except)
- •Patients with IBD: Informed Written consent
- •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)
- •For volunteers: Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day
- •For volunteerss: - Patient with health insurance (AME except)
- •For volunteers: Informed Written consent
- •Patients with IBD: Age ≥ 18 ans et < 50 ans avec IMC compris entre 17 et 25 kg/m²
- •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)
- •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).
- •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%)
排除标准
- •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).
- •Patients with IBD: Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- •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
- •Healthy volunteers: Curative long-term treatment
- •Patients with IBD: Participation in any other interventional study
- •Patients with IBD: Patients under legal protection
- •Patient with IBD: Diagnosis of ulcerative colitis restricted to the rectum
- •Healthy volunteers : Pregnant or breastfeeding women
- •Healthy volunteers : blood donation in the 3 months before the study
- •Healthy volunteers: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1)
- •Healthy volunteers : probiotics in the month preceding day 0 (V1)
- •Healthy voluteers: contra-indications to the administration of gentamicin (refer to SmPC)
- •Healthy volunteers: consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0
- •Healthy volunteers: abdominal surgery in the past (except for appendectomy)
- •Healthy volunteers: allergy against the antibiotics and antifungal treatment used in this study or to their excipients
- •Healthy volunteers: fructose intolerance
- •Patient with IBD: Fructose intolerance
- •Healthy volunteers: Participation in any other interventional study
- •Healthy volunteers: under legal protection
- •Patients with IBD: Pregnant or breastfeeding women
- •Patients with IBD: blood donation in the 3 months before the study
- •Patients with IBD: Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0
- •Patients with IBD: probiotics in the month preceding day 0 and during the study
- •Patients with IBD: Ileal resection > 50cm or colectomy
结局指标
主要结局
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
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
次要结局
- 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
- 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
研究者
Pr
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCTGraft Vs Host DiseaseNCT06143501The First Affiliated Hospital of Soochow University250
招募中
不适用
The role of gut microbiota and chronic inflammation as drivers of cardiovascular disease - Nijmegen Biomedical Study - Non Invasive markers of Atherosclerosis 3atherosclerosiscardiovascular diseaseNL-OMON38378niversitair Medisch Centrum Sint Radboud500
Unknown
不适用
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in HumansPhysical AbilitiesFMTNCT05024188Assaf Harofeh MC50
招募中
不适用
Exploring the modulatory effects of gut microbiota on cholangiocarcinoma progression in a patient-derived organoid modelC22.1Intrahepatic bile duct carcinomaCholangiocarcinomaDRKS00033188nimedizin Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie20
Unknown
不适用
"The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"Colorectal CancerGastric CancerNCT04980950Medical University of Gdansk80