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 | NCT05202990 (ClinicalTrials.gov) | March 2023 | 10/1/2022 | Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis | Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis. | Pediatric Ulcerative Colitis in Remission | Drug: Fecal Microbiota Transplantation by Stool capsules;Drug: Fecal Microbiota Transplantation by Intra-rectal enemas | Assistance Publique - Hôpitaux de Paris | MRSU 938 - Research Center of Saint Antoine | Not yet recruiting | 8 Years | 17 Years | All | 26 | Phase 2 | France |
| 2 | 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 |
| 3 | 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 |
| 4 | NCT05030064 (ClinicalTrials.gov) | September 10, 2021 | 9/8/2021 | Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression | Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression | Ulcerative Colitis | Drug: Intestinal flora capsule;Procedure: placebo capsule | Third Military Medical University | NULL | Recruiting | 18 Years | 65 Years | All | 54 | N/A | China |
| 5 | NCT04373473 (ClinicalTrials.gov) | September 14, 2020 | 28/4/2020 | Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis | A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis | Adults With Ulcerative Colitis | Drug: PRIM-DJ2727;Drug: Placebos | The University of Texas Health Science Center, Houston | NULL | Recruiting | 18 Years | N/A | All | 58 | Phase 2 | United States |
| 6 | NCT05538026 (ClinicalTrials.gov) | September 1, 2020 | 9/9/2022 | Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial | Ulcerative Colitis Chronic Mild;Inflammatory Bowel Diseases | Drug: Mesalazine;Biological: Fecal transplantation | Bogomolets National Medical University | Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine | Completed | 18 Years | 60 Years | All | 53 | N/A | Ukraine |
| 7 | 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 |
| 8 | NCT04521205 (ClinicalTrials.gov) | September 2020 | 18/8/2020 | A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Inflammatory Bowel Disease, Ulcerative Colitis Type | Drug: fecal microbiota capsule | Zhongshan Hospital Xiamen University | NULL | Recruiting | 18 Years | 65 Years | All | 200 | Phase 1 | China |
| 9 | 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 |
| 10 | 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 |
| 11 | NCT03716388 (ClinicalTrials.gov) | December 1, 2018 | 21/10/2018 | Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC | Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Biological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granules | Dayanand Medical College and Hospital | Colitis & Crohn's Foundation (India) | Recruiting | 18 Years | 75 Years | All | 20 | Phase 3 | India |
| 12 | 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 |
| 13 | EUCTR2017-004967-11-FR (EUCTR) | 26/06/2018 | 06/04/2018 | Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis. | Poca - Poca | Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized MedDRA version: 20.1;Level: LLT;Classification code 10000638;Term: Active ileal inflammation;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: suspension de microbiote fécal Product Code: PRD5973697 | CHU Nantes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France | ||
| 14 | NCT03378921 (ClinicalTrials.gov) | February 27, 2018 | 11/12/2017 | Fecal Microbiota Transplantation in the Treatment of Pouchitis | Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis | Pouchitis;Ulcerative Colitis | Biological: Fecal microbiota transplantation;Biological: Placebo | Helsinki University Central Hospital | NULL | Completed | 18 Years | 75 Years | All | 26 | Phase 2 | Finland |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 | |
| 18 | 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 |
| 19 | 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 |
| 20 | NCT02390726 (ClinicalTrials.gov) | December 2015 | 19/2/2015 | Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis | Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis | Ulcerative Colitis, Active Moderate | Biological: Fecal Microbiota Transplant;Biological: Placebo | University of Vermont | NULL | Unknown status | 18 Years | 75 Years | All | 20 | Early Phase 1 | United States |
| 21 | NCT02636517 (ClinicalTrials.gov) | December 2015 | 16/12/2015 | Fecal Microbiome Transplant | Fecal Microbiome Transplant in Pediatric C. Difficile | Clostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Children's Hospital of Philadelphia | NULL | Active, not recruiting | 3 Years | 21 Years | All | 250 | N/A | United States |
| 22 | 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 |
| 23 | 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 |
| 24 | JPRN-UMIN000018642 | 2015/08/12 | 11/08/2015 | A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis | A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis - A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis | ulcerative colitis | Antibiotics therapy:Taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks. FMT:Administration of the fecal material from healthy donors to patients. | Juntendo university school of medicine Department of gastroenterology | NULL | Complete: follow-up complete | 6years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 25 | NCT02435160 (ClinicalTrials.gov) | May 2015 | 23/4/2015 | The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Biological: Fecal Microbiota Transplantation | Jun Liu | NULL | Not yet recruiting | 25 Years | 60 Years | Male | 20 | Phase 2/Phase 3 | NULL | |
| 26 | NCT02575040 (ClinicalTrials.gov) | May 2015 | 6/10/2015 | Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease | Ulcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction) | Biological: Fecal microbiota transplantation | Gulhane Military Medical Academy | NULL | Recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Turkey |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | NCT02058524 (ClinicalTrials.gov) | June 2013 | 27/8/2013 | A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis | A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis | Biological: fecal microbiota transplantation | University of Chicago | NULL | Terminated | 18 Years | 65 Years | Both | 1 | Phase 1 | United States |
| 35 | 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 |