97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 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 | NCT05739864 (ClinicalTrials.gov) | February 13, 2023 | 13/2/2023 | Superdonor FMT in Patients With Ulcerative Colitis | Evaluation of the Efficacy of Superdonor Fecal Microbiota Transplantation in Patients With Mild-to-moderate Ulcerative Colitis: a Double-blind Randomized Controlled Trial | Active Ulcerative Colitis | Biological: FMT;Other: Placebo FMT | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | NULL | Recruiting | 18 Years | 75 Years | All | 42 | Phase 1/Phase 2 | Italy |
| 2 | NCT04968951 (ClinicalTrials.gov) | November 10, 2021 | 9/7/2021 | Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC) | REFOCUS: Refined Fecal Microbiota Transplantation (FMT) Delivered by Oral Capsules for Induction of Remission in Mild to Moderate Ulcerative Colitis - a Phase I Study | Ulcerative Colitis;FMT;Fecal Microbiota Transplant | Drug: Metronidazole;Drug: Placebo;Drug: Vancomycin;Biological: Fecal Microbiota Transplantation | Ari M Grinspan | NULL | Recruiting | 18 Years | 75 Years | All | 20 | Early Phase 1 | United States |
| 3 | 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 |
| 4 | NCT04202211 (ClinicalTrials.gov) | February 2020 | 13/12/2019 | FMT for Remission of Active Ulcerative Colitis in Adults | A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Biological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enema | University of British Columbia | Crohn's and Colitis Canada;Vancouver Island Health Authority | Not yet recruiting | 18 Years | N/A | All | 145 | Phase 2 | Canada |
| 5 | NCT03998488 (ClinicalTrials.gov) | January 31, 2020 | 24/6/2019 | Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis | A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk Powder | Weill Medical College of Cornell University | Crohn's and Colitis Foundation | Recruiting | 18 Years | 89 Years | All | 135 | Phase 2 | United States |
| 6 | NCT03483246 (ClinicalTrials.gov) | September 17, 2018 | 26/2/2018 | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial | Ulcerative Colitis | Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation Placebo | Assistance Publique - Hôpitaux de Paris | CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France | Recruiting | 18 Years | 74 Years | All | 150 | Phase 3 | France |
| 7 | NCT03477032 (ClinicalTrials.gov) | June 1, 2018 | 19/3/2018 | FMT in Inflammatory Bowel Disease | Faecal Transplantation in Inflammatory Bowel Disease | Faecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic Colitis | Biological: Faecal Microbiota Transplantation | St Vincent's Hospital Melbourne | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Australia | |
| 8 | ChiCTR2100043797 | 2018-01-01 | 2021-02-28 | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | Ulcerative colitis | Case series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.; | Department of Gastroenterology, Jinan Central Hospital | NULL | Completed | 21 | 81 | Both | Case series:28; | N/A | China |
| 9 | EUCTR2015-005753-12-GB (EUCTR) | 22/11/2017 | 02/08/2018 | A research study looking at faecal transplant as a treatment for ulcerative colitis, and the best way to use it in children and adults with the condition | Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis. - STOP-Colitis Pilot Trial | Ulcerative colitis for at least 3 months prior to trial entry;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Faecal Microbiota Transplant Product Code: FMT INN or Proposed INN: faecal matter | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | United Kingdom | ||
| 10 | NCT03006809 (ClinicalTrials.gov) | March 2, 2017 | 21/12/2016 | Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis | Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbiota Transplantation (FMT), OpenBiome;Other: pretreatment antibiotics | Najwa Elnachef | NULL | Completed | 18 Years | 64 Years | All | 30 | Phase 1 | United States |
| 11 | 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 |
| 12 | NCT02516384 (ClinicalTrials.gov) | October 1, 2016 | 29/7/2015 | Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) | Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) | Ulcerative Colitis | Biological: Fecal Microbiota Transplantation | Weill Medical College of Cornell University | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 13 | JPRN-UMIN000026485 | 2016/08/01 | 10/03/2017 | Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. | Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. - Research on the Efficacy of FMT to the Children with UC | ulcerative colitis | Fecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day. | National Center for Child Health and Development | 10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, Japan | Recruiting | 2years-old | 18years-old | Male and Female | 12 | Not selected | Japan |
| 14 | NCT02330653 (ClinicalTrials.gov) | November 2015 | 29/12/2014 | Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis | A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's Colitis | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo | Stacy A. Kahn | NULL | Completed | 5 Years | 30 Years | All | 15 | Phase 1/Phase 2 | United States |
| 15 | NCT02335281 (ClinicalTrials.gov) | January 2015 | 7/1/2015 | Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Procedure: FMT;Drug: Mesalazine | Yanling Wei | NULL | Recruiting | 16 Years | 70 Years | Both | 40 | Phase 2 | China |
| 16 | NCT02049502 (ClinicalTrials.gov) | July 2014 | 27/1/2014 | FMT in Ulcerative Colitis-Associated Pouchitis | The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis | Ulcerative Colitis Associated Pouchitis | Biological: biologically active human fecal microbiota;Procedure: sigmoidoscopy | Virginia O. Shaffer | NULL | Completed | 18 Years | 65 Years | All | 8 | Phase 2 | United States |
| 17 | NCT02227342 (ClinicalTrials.gov) | July 2014 | 22/7/2014 | Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis | A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbiota Transplant | University of Alberta | NULL | Completed | 18 Years | 65 Years | Both | 3 | Phase 1/Phase 2 | Canada |
| 18 | JPRN-UMIN000014152 | 2014/06/04 | 04/06/2014 | A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitis | A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitis - A trial of a combination therapy of FMT and antibiotics or FMT for ulcerative colitis | ulcerative colitis | Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks | Juntendo university school of medicine Department of gastroenterology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 19 | NCT02108821 (ClinicalTrials.gov) | March 2014 | 21/3/2014 | Fecal Microbiota Transplantation in Pediatric Patients | A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease. | Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Children's Mercy Hospital Kansas City | University of Pittsburgh;Stanford University | Completed | 2 Years | 22 Years | All | 23 | Phase 1 | United States |
| 20 | NCT01947101 (ClinicalTrials.gov) | February 2014 | 13/9/2013 | Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children | A Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC) | Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Baylor College of Medicine | NULL | Completed | 12 Years | 20 Years | Both | 6 | Phase 1 | United States |
| 21 | NCT02033408 (ClinicalTrials.gov) | January 2014 | 3/12/2013 | Manipulating the Microbiome in IBD by Antibiotics and FMT | Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial | Exacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's Colitis | Drug: AB (antibiotics);Drug: CS (corticosteroids) Only | Shaare Zedek Medical Center | NULL | Completed | 2 Years | 75 Years | All | 28 | N/A | Canada;Finland;Israel;Italy;Poland;Spain |
| 22 | NCT01896635 (ClinicalTrials.gov) | November 2013 | 6/7/2013 | Faecal Microbiota Transplantation in Ulcerative Colitis | Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety | Ulcerative Colitis;Inflammatory Bowel Disease | Biological: FMT infusions;Other: Placebo infusion | The University of New South Wales | NULL | Completed | 18 Years | 75 Years | Both | 81 | Phase 2 | Australia |
| 23 | NCT01790061 (ClinicalTrials.gov) | November 2012 | 9/2/2013 | Standardized Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis | Bacteria;Microbiota;Fecal Microbiota Transplantation;Inflammatory Bowel Disease;Ulcerative Colitis | Procedure: Standardized FMT;Drug: Traditional treatments | The Second Hospital of Nanjing Medical University | Air Force Military Medical University, China | Recruiting | 6 Years | 80 Years | All | 500 | Phase 2/Phase 3 | China |