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 | 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 |
| 2 | NCT04979832 (ClinicalTrials.gov) | September 6, 2021 | 30/6/2021 | GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery | A Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis Surgery | Pouchitis | Drug: GM-CSF, fosfomycin and metronidazole | Zealand University Hospital | NULL | Recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | Denmark |
| 3 | EUCTR2020-000609-10-DK (EUCTR) | 06/07/2021 | 23/09/2020 | A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patients | A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study | A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch. MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Repomol INN or Proposed INN: Molgramostim Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: Metronidazole Trade Name: Fosfomycin Product Name: Infectofos INN or Proposed INN: Fosfomycin disodium Other descriptive name: FOSFOMYCIN DISODIUM | Center for Surgical Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 1;Phase 2 | Denmark | ||
| 4 | NCT03986996 (ClinicalTrials.gov) | July 25, 2019 | 4/6/2019 | Antimicrobial Therapy for Ulcerative Colitis (UC) | Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: amoxicillin, metronidazole and doxycycline;Drug: amoxicillin and doxycyclin | Wolfson Medical Center | NULL | Terminated | 13 Years | 60 Years | All | 20 | Phase 2 | Israel |
| 5 | NCT03794765 (ClinicalTrials.gov) | April 1, 2019 | 4/1/2019 | Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis | Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial | Ulcerative Colitis;Inflammatory Bowel Diseases;Acute Severe Colitis | Drug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusion | Postgraduate Institute of Medical Education and Research | NULL | Completed | 13 Years | N/A | All | 50 | Phase 2 | India |
| 6 | 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 |
| 7 | JPRN-UMIN000025846 | 2017/02/01 | 01/02/2017 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease - A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | ulcerative colitis, Crohn's disease | 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 medicineDepartment of gastroenterology | NULL | Recruiting | 16years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 8 | 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 |
| 9 | NCT02606032 (ClinicalTrials.gov) | May 2016 | 13/11/2015 | Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis | Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis | Ulcerative Colitis | Drug: Metronidazole;Drug: Doxycycline;Drug: Terbinafine;Drug: Placebo | Hamilton Health Sciences Corporation | Hamilton Academic Health Sciences Organization | Completed | 18 Years | N/A | All | 75 | Phase 2 | Canada |
| 10 | 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 |
| 11 | JPRN-UMIN000017844 | 2015/06/22 | 22/06/2015 | Antibiotic combination therapy for ulcerative colitis | Antibiotic combination therapy for ulcerative colitis - Antibiotic combination therapy for ulcerative colitis | ulcerative colitis | amoxicillin, tetracycline, and metronidazole | Shiga University of Medical Science | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Not selected | Japan |
| 12 | 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 |
| 13 | JPRN-UMIN000009811 | 2013/01/23 | 21/01/2013 | Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis | Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitis | Ulcerative colitis | One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint). Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months. | Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 40 | Phase 3 | Japan |
| 14 | EUCTR2009-015136-14-BE (EUCTR) | 20/11/2009 | 12/10/2009 | Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study | Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study | Pouchitis MedDRA version: 12.0;Level: LLT;Classification code 10036463;Term: Pouchitis | Product Name: Metronidazole capsule 50 mg Product Code: FP-110 INN or Proposed INN: Metronidazole Trade Name: Flagyl INN or Proposed INN: Metronidazole | FORMAC Pharmaceuticals NV | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 15 | JPRN-UMIN000048515 | 2008/10/01 | 31/07/2022 | A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients | A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients - A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients | Ulcerative colitis | 14 days oral intake of amoxicillin 1500 mg/day, tetracycline 1500 mg/day and metronidazole 750 mg/day | Juntendo University | NULL | Complete: follow-up continuing | 18years-old | Not applicable | Male and Female | 350 | Not selected | Japan |
| 16 | NCT00355602 (ClinicalTrials.gov) | July 2006 | 21/7/2006 | Antibiotics for the Treatment of Ulcerative Colitis | Use of Antibiotics to Eradicate Bacterial Pathogens Colonising the Colonic Mucosa in Ulcerative Colitis Patients | Colitis, Ulcerative | Drug: Cefuroxime;Drug: Ciprofloxacin;Drug: Clarithromycin;Drug: Cotrimoxazole;Drug: Coamoxiclav;Drug: metronidazole;Drug: neomycin;Drug: rifaximin;Drug: Vancomycin;Drug: Doxycycline | University of Dundee | Tenovus Scotland | Completed | 18 Years | 79 Years | Both | 40 | N/A | United Kingdom |
| 17 | JPRN-C000000078 | 2003/10/01 | 26/08/2005 | Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study | Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study - Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis | Ulcerative Colitis | Patients in the treatment group receive an antibiotic combination consisting of amoxicillin 500mg tid, tetracycline 500mg tid, and metronidazole 250mg tid for two weeks. patients in the control group recieve three kinds of placebo contained sugar. | Japan UC Antibiotics-therapy Study Group(JUCASG) | Nihon University,Iwate Medical University, Kyoto Central HospitalYamagata Central HospitalOita University, Tokyo Medical UniversityToyama Medical & Pharmaceutical University, Showa University | Complete: follow-up complete | 15years-old | 70years-old | Male and Female | 210 | Phase 2 | Japan |