97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCTs031200103 | 01/09/2020 | 01/09/2020 | Alginate combined fecal microbiota transplantation for ulcerative colitis | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | Ulcerative colitis Ulcerative colitis | A-FMT plus algin acid therapy arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take algin acid two times a day every single day. A-FMT plus placebo arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take Placebo two times a day every single day. | Ishikawa Dai | NULL | Recruiting | >= 20age old | Not applicable | Both | 60 | N/A | Japan |
| 2 | NCT03804931 (ClinicalTrials.gov) | January 20, 2019 | 6/1/2019 | Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Procedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone | Guangzhou First People's Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 120 | Phase 2/Phase 3 | China |
| 3 | NCT02994836 (ClinicalTrials.gov) | April 21, 2017 | 24/10/2016 | GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) | Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation | Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis | Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus) | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Active, not recruiting | 18 Years | N/A | All | 194 | Phase 4 | Spain |
| 4 | JPRN-jRCTs031180415 | 01/02/2017 | 22/03/2019 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) | AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults). FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. A-FMT arm : Patient undergoes FMT two days after AFM therapy. | Ishikawa Dai | NULL | Recruiting | >= 6age old | Not applicable | Both | 120 | N/A | Japan |
| 5 | NCT02998112 (ClinicalTrials.gov) | December 2016 | 13/12/2016 | Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing | Ulcerative Colitis | Drug: fecal microbiota transplantation;Drug: Saline | The Second Hospital of Nanjing Medical University | Fourth Military Medical University;First Hospital of Guangzhou;Daping Hospital and the Research Institute of Surgery of the Third Military Medical University;Zhongshan Hospital Xiamen University | Recruiting | 18 Years | 65 Years | Both | 188 | Phase 4 | China | |
| 6 | NCT02487238 (ClinicalTrials.gov) | November 2015 | 25/6/2015 | Pediatric FEcal Microbiota Transplant for Ulcerative Colitis | A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified | Inflammatory Bowel Disease;Ulcerative Colitis | Biological: Fecal Microbiota Enema;Biological: Normal Saline Enema | McMaster Children's Hospital | London Health Sciences Centre;St. Justine's Hospital | Completed | 3 Years | 17 Years | All | 35 | Phase 1 | Canada |
| 7 | NCT02084550 (ClinicalTrials.gov) | September 2015 | 5/3/2014 | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial | Ulcerative Colitis | Dietary Supplement: Vaminolac;Other: Saline | Aarhus University Hospital | NULL | Active, not recruiting | 18 Years | 50 Years | All | 8 | N/A | Denmark |
| 8 | NCT02442037 (ClinicalTrials.gov) | May 2015 | 6/5/2015 | Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis | Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis. | Ulcerative Colitis | Biological: UCMSC group;Other: Control group(Normal saline) | Affiliated Hospital to Academy of Military Medical Sciences | Ivy Institute of Stem Cells Co. Ltd | Recruiting | 18 Years | 65 Years | Both | 30 | Phase 1/Phase 2 | China |
| 9 | NCT00656890 (ClinicalTrials.gov) | April 2008 | 4/4/2008 | A Study of MDX-1100 in Subjects With Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Biological: sterile saline for injection;Biological: MDX-1100 | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 110 | Phase 2 | United States;Canada;Czech Republic;Hungary;Latvia;Romania;Russian Federation;Ukraine |